# EnteraGam alternative discussion



## Getreal (Aug 1, 2012)

I went to my gastro doc for this but he has not heard of it and won't prescribe. However, on Amazon I found bovine serum immunoglobulin and ordered it -- what is the difference, anybody know? And if there really isn't a difference, the supplements currently available are WAY CHEAPER.


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## legbuh (Jan 9, 2005)

I truly think it's just another company out to steal money from us.

Why is it RX only being just a simple protein/amino acid? Money... insurance pays for it. Not yet, but it will. At first just get the low lying fruit that will pay out of pocket huge prices. Then get the gov't to subsidise and offer $75 bucks off.

Then, open the floodgates for insurance to cover it.


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## Kathleen M. (Nov 16, 1999)

Why prescription?

Because if they sell it as a medical food they can make claims about treatment for diseases and market it that way.

If they were selling it as a supplement for maintaining health in healthy people it would still be all about making money. Really, supplements and health food store stuff is still big business and all about the profit margin.

Also as a medical food they probably have to actually prove on a regular basis what is on the label is actually in the product to the FDA, like any other prescribed product.

Honestly, I suspect they could make as much or more money selling it as an unregulated product with vague claims about what it might kinda do.

If they sold it on the web for where if you spend $180 dollars at a time you get one of the bottles for free would you trust them more? Would that be about helping people more than doing what is needed for the FDA? At least it sounds like their business model includes the testing and quality control needed to get the designation of medical food.

Yeah it may mean they have a higher price to make the same profit margin they would if they sold it at the health food store, but the Quality Assurance and testing to make sure it actually does something does cost a business money, and most supplement companies are doing everything they can to make sure they never have to be burdened with those costs. Based on how many of them fail the independent quality testing, to many of them aren't going to want to spend the money on making a quality product that can regularly pass the FDA testing needed for prescription or other over the counter medications.

It just seems that a company wanting to do things the way that forces them to do things the right way shouldn't be such a huge negative for everyone, but I guess I just don't get why certain business models are so evil.


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## Getreal (Aug 1, 2012)

I agree with much of what is being said here-- we need quality control and science to ensure the results of medicines or supplements (especially since we are a rather desperate group!). I guess my confusion is simply that this product/supplement is fairly basic and I am finding serum bovine immunoglobulin everywhere. Kinda like suddenly charging a lot for special bananas. Okay that is a terrible metaphor but you get my drift.

I suppose a better comparison would be the $$$ of VSL#3 vs the cheapness of yogurt or other probiotics? VSL#3 does have the research and the quality control, but some of the other sources of similar are available cheaper and more widely?

My hope is that this is a real tool and will help a lot of people. I also hope the stuff in EnteraGam is the same stuff widely available at affordable prices.


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## Kathleen M. (Nov 16, 1999)

One of the problems with the supplement market it is it really hard to judge if anything in the store is the same thing as something that may be sold in a more regulated market.

Even for what should be a cheap supplement there are plenty of people selling the whatever it is for way more than any company would charge for it if they did do the prescription/FDA/medical food route.

VSL#3 is also more expensive per dose because they have a lot more bacteria per dose. If you do an analysis where you normalize per billion organisms they are in the same range as anyone else.

If you do decide to go with the cheapest possible source of something (and heck sometimes it is the supplement that is way more expensive that flunks the test) it may be worth checking Consumer Labs and see if they have analyzed it, yet. They catch a lot of the places that have quality control standards that may not match what you would wish they would be. So those with much less or much more than is on the label, at least some known common toxins that get in some things (some sources of some compounds are often contaminated with lead).


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## Getreal (Aug 1, 2012)

Good points! Ok, so my recent Amazon purchase, a bovine serum immunoglobulin (what EnteraGam says it is) is "cGMP compliant." I looked this term up and it seems to suggest some FDA involvement.

I am leaving out brand names just in case, but this is the supplement description:

is a purified, highly concentrated (45%), very low saturated fat, dairy free, consistent source of bovine serum-derived immunoglobulin antibodies and immunoproteins that provide immune enhancement by directly boosting immunoglobulin levels in the GI tract. Oral immunoglobulins have proven efficacy against bacteria, viruses, protozoa, and fungus. This spray-dried powder with a neutral flavor and odor also contains beneficial growth factors and immune-regulating cytokines.


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## Moises (May 20, 2000)

Based on this thread and my own Googling, here are some initial findings:

There is a company called Proliant which manufactures a serum bovine immunoglobulin that it calls Immunolin. Proliant sells Immunolin to the supplement industry and it is easy to find various supplements on the web containing Immunolin either alone or in combination with other substances.

Immunolin is serum bovine immunoglobulin. Enteragram is serum bovine immunoglobulin. Immunolin is classified as GRAS by the FDA. That means "generally recognized as safe." This is certainly a lower standard than the "medical food" status of Enteragram.

I don't want to use this forum for discussing my political opinions. Suffice it to say that manufacturers of supplements and manufacturers of prescription drugs will both do what they can to increase profits.

But I am going to approach this from the viewpoint of the rational consumer. I know that I am a consumer. You can judge how rational I may or may not be.

1. I do not know how the Immunolin immunoglobulins compare to the Enteragram immunoglobulins, but there is a strong suspicion, based on reading the package insert of Enteragram, that they are identical.

2. I know that the Immunolin immunoglobulins have been in the US marketplace for about 4 years and there is little evidence that anyone has been damaged by them.

3. I know that the Immunolin immunoglobulins are much lower in price than the Enteragram immunoglobulins.

4. I know that I can purchase Immunolin in a form that contains no excipients and that Enteragram is only available with 5 grams of carbohydrate added.

5. I know that my blood sugar rises about 4 mg/dl (0.222 mmol/L) for each gram of carbohydrate I consume.

6. I know that numerous studies demonstrate that each increase in HbA1c (blood sugar) even in nondiabetics, increases the the odds of Alzheimer's, all-cause mortality, and cardiac disease.

7. I know that the manufacturers of Enteragram are coming out with a dextrose-free version of their product in the future.

8. I know that I can purchase Immunolin without first expending the time and money trying to convince a physician that I should get a prescription for Enteragram.

Given all the above, it seems rational for me, as someone with IBS, to give Immunolin a try. Whether it improves my condition or not, it also makes sense for me to try to get some of the dextrose-free Enteragram when it hits the market in the future.

Companies that market substances to us are trying to make money. We consumers are trying to get better at the lowest possible cost. We should not take unnecessary risks. We should avoid drugs and supplements that carry substantial risk. Both drugs and supplements can cause harm. In the case of Enteragram and Immunolin the risks of either one appear to be quite low. The cost of the former is much higher than the latter.


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## Moises (May 20, 2000)

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CC4QFjAA&url=http%3A%2F%2Fpag.aids2012.org%2FPAGMaterial%2FPPT%2F1286_2287%2Faids2012%2520tuaa03%2520-%2520sgalt%2520oral%2520v7.pptx&ei=CB-VUq2xDefdsATWz4LQAg&usg=AFQjCNHfXpKs519QWaRzzYeb8TjEzljYCg&sig2=-Dj-UEb0WM9OpST7SRHu-A&bvm=bv.57155469,d.cWc&cad=rja

The link above is a Powerpoint presentation funded by the makers of Enterahealth. On slide 3, footnote 4, they cite the Immunolin website to support their claims about SBI.


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## Getreal (Aug 1, 2012)

Thank you very much for doing this research and sharing it with us here. It is quite helpful.


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## IBS2 (Feb 7, 1999)

A great deal of thanks to Moises for his research into this interesting topic. Now it seems the only question is will this new treatment work? The good news is, if Moises is correct and the Proliant Immunolin version of this product is the therapeutic equivalent of Enteragam, the quicker we can get enough people using the product to get an answer to just how much benefit IBS patients will get.


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## gdf90 (Nov 24, 2013)

Hello, I read your post and would like to know where you can buy Immunolin or other similar products ( alone or in combination with other substances) . Do you give me some link or address? Thanks


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## Moises (May 20, 2000)

Two products with Immunolin:

Now Foods Immune Advantage

Xymogen IgG 2000 DF

I don't know about their availability in Italy. Why don't you let us know if you found them.


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## gdf90 (Nov 24, 2013)

Moises said:


> Two products with Immunolin:
> 
> Now Foods Immune Advantage
> 
> ...


Dear Moises thanks for your help. Which you have chosen between the two products?
If I read correctly, Immunolin seem that is only present in Foods Immune Advantage.
I tried to compare the ingredients of the two products.

*Xymogen IgG 2000 DF *
Serving size 2 capsules
*IgG 2000 DF* ™ (providing concentrated serum -derived immunoglobulin IgG,IgA,IgM,IgE,IgD . Provides transferrins Also , IGF -1 and TGFß -1) *1.25 g* *Immunoglobulin G* (IgG) *562.5 mg .*

*Other Ingredients: HPMC (*capsule*) *vegetable stearic acid, vegetable magnesium stearate and silica.

*Now Foods Immune Advantage*
Serving Size: 1 Capsules
*Immunolin ™* ( from Bovine Serum Immunoglobulin Concentrate ) *450 mg (950 mg for 2 capsules)*
Typical Profile of naturally occurring nutrients per serving*
*Immunoglobulin G (IgG)* *180 mg (360 mg for 2 capsules)*
*Transferrins* *40.5 mg*
*Proline -rich polypeptides *( Immunoregulators ) *22.95 mg *
*Immunoglobulin M* (IgM) *20.25 mg*
*Immunoglobulin A* ( IgA) *2.25 mg*
*IGF1 2.4 mcg *

*Other Ingredients: * Gelatin (capsule) and Magnesium Stearate (vegetable source).

*Contains no:* sugar, salt, starch, yeast, wheat, gluten, corn, soy, milk, egg, shellfish or preservatives.

ImmunoLin® is a registered trademark of Proliant, Inc.

I want to ask you and the other friends of the forum :
1) What Enteragam label says about ingredients?
2)Which do you think is the most similar to Enteragam ?

3)What are the differences between these products and Enteragam do you think?
Maybe for me it's easier to buy Now Foods Immune Advantage I saw that they sell on ebay but first I would like your advice.
thanks


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## Moises (May 20, 2000)

gdf90,

1. Enteragram is serum bovine immunoglobulin (SBI) with 5 grams of dextrose per serving

2. I have no reason to think that there is any difference between Xymogen's product and NOW Foods' product or any other product that contains Immunolin.

3. I do not have sufficient knowledge to answer this question. Both Enteragram and Immunolin are serum bovine immunoglobulin. Things I do not know:


Are the manufacturing processes the same?
Are they manufactured in the same plant?
Do they use the same breeds of cattle?
Are either of these products identical to the products that have a long history of use with animals?

In this journal article:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3754419/

the experimenters used Enteragram. To justify this experiment with humans with HIV they cite numerous experiments (references 22-28) that used an SBI that does not appear to be Enteragram. The authors make no claim that the SBI in Enteragram differs in any way from the SBI that has a long history of use in animal husbandry or the SBI in Immunolin that has received GRAS status from the FDA in 2008 (reference 40 in the Asmuth et. al. article linked above).


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## IBS2 (Feb 7, 1999)

Has anyone looked at Extreme Immunity. From the looks of it the dosage 5GM is similar to Enteragam. Amazon has it for 59 dollars. Just want to make sure its the same type of product.


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## jstezelecki (Sep 23, 2013)

I have no idea if the Bovine Immunoglobins used in some of these supplements are the same as the medical food made by Enteragam but the research recently done by Immune Therapy Research Labatory regarding the immunoglobins is interesting and hopeful for IBS D sufferers. I checked out the ITRL site and was very impressed.

www.oramune.com/custom.aspx?id=15


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## PD85 (Aug 19, 2010)

IBS2 said:


> Has anyone looked at Extreme Immunity. From the looks of it the dosage 5GM is similar to Enteragam. Amazon has it for 59 dollars. Just want to make sure its the same type of product.


I have looked into this and I believe it is not the same as EnteraGam or Immunolin. The ingredients say "Serum Albumin Concentrate" and lists 4g of protein, 2.4g of Albumin, and 700mg of IgG.


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## Jeffrey Roberts (Apr 15, 1987)

I wrote about Xymogen's IgG2000 product in another post:



> It is my understanding that Xymogen's IgG2000 has no ongoing relationship with the prescription-based EnteraGam. The product Xymogen is selling is not the same product as the prescription-based EnteraGam. Also, I am not aware that Xymogen has any published clinical studies on IgG2000's use specifically for IBS. EnteraGam is not approved by the FDA. EnteraGam is regulated under the Orphan Drug Act by the FDA as a prescription medical food product. Medical supervision is required.
> 
> As there are many products on the market which claim to be a treatment for IBS, it is always best to discuss with your own physician which evidenced-based treatment you might consider.


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## IBS2 (Feb 7, 1999)

Nadine,

Thanks for the information. The big question now is, how have you been doing taking the Intestive? To what degree of control of your IBS has Intestive helped?


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## PD85 (Aug 19, 2010)

I found another product in this "category" of products. It's actually a bodybuilding supplement. Of course it's not marketed towards anything except bodybuilding but I wonder if it would help IBS? Here is a link with all the info:

http://www.nutraplanet.com/product/man/pure-pf3-50-servings.html?sel=5909

And here is even another Bodybuilding supplement that seems related:

http://www.bodybuilding.com/store/isatori/bio-gro.html


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## Cory (Oct 27, 2013)

Hi All,

I have purchased the product Getreal noted in his/her post from Amazon. It's been less than a week but I can already see a difference. Not a huge difference mind you, but a difference. I am reserving judgement because this has happened in the past. I try something new and oooooo! Then I'm right back to "normal". I have stopped my Imodium regimen for now so I can see if this stuff works, so far it hasn't been too horrible.

I will keep going and take the entire bottle (1 month supply) as I know this can take some time. I'll post as I go along if anyone is interested.


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## jstezelecki (Sep 23, 2013)

After reviewing all the comments and then reviewing the EnterGam package information that is available, it appears to me that some supplements may have some of the ingredients of EnteraGam but the are not EnteraGam. According to EnteraGam there is no other medical food on the market like it, nothing like it is available over the counter and it's contents are only available through a prescription. They also state that it is not available in generic form. This all makes sense, I doubt that they would have spent millions on bring this product to market without some kind of product patent protection.

I'm just hoping that enough folks can afford the product test it to see if it will do what the research labs say they think it can do. Right now I'm building a supply of my free samples and hope to start taking it soon.

John


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## Moises (May 20, 2000)

John,

Were you in contact with the makers of EnteraGam or did you come to these conclusions from the Enteragam insert, below?

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&ved=0CCwQFjAA&url=http%3A%2F%2Fwww.enteragam.com%2Fwp-content%2Fuploads%2F2013%2F10%2FEnteraGAM-full-prescribing-info.pdf&ei=rTOfUq3_LunLsASNuoEY&usg=AFQjCNHj8slAM0u4QOwSS90XwmbgYYVIJg&sig2=DjHlyrm48WgWs0ysvmiRaw&bvm=bv.57155469,d.cWc

You write that "there is no other medical food on the market like it . . ." I would agree with that statement because only EnteraGam has been granted "medical food" status by the FDA.

You write that "its contents are only available through a prescription." This agrees with Jeffrey Roberts' statement, above, that Immunolin "is not the same product" as EnteraGam.

If you or Jeffrey are in contact with EnteraGam's manufacturers, perhaps you can provide more detail.

In a very narrow sense, EnteraGam and Immunolin appear to be different products. First, they are packaged differently. I believe that only EnteraGam comes in packets. Second, EnteraGam contains dextrose. I do not believe that any products containing Immunolin also contain dextrose. Third, EnteraGam's lecithin is derived from sunflower, while Immunolin's lecithin is derived from soy.

I do not view the three differences listed above as substantive difference. What would be a substantive difference would be evidence supporting the claim that the SBIs (serum bovine immunoglobulins) in EnteraGam are qualitatively or quantitatively different than the SBIs in Immunolin.

I do not know if the two products contain different SBIs and I welcome anyone who can offer information on this.

From what I have been able to determine so far, EnteraGam has GRAS (generally recognized as safe) status from the FDA because EnteraGram inherited its GRAS status from Immunolin:

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&ved=0CCwQFjAA&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Ffcn%2Fgras_notices%2F710670A.PDF&ei=YDifUuaKL7OmsQSR-YCQBg&usg=AFQjCNG0tCySHFfVNTVqekhJNbWcvUp8NA&sig2=sCtKlELhAeIIrOXJb3d28g&bvm=bv.57155469,d.cWc

If that is true, then the FDA considers EnteraGam GRAS because it is substantively the same as Immunolin.

Here is the logic:

1. Immunolin is GRAS.

2. EnteraGam is substantially the same as Immunolin.

3. Therefore, EnteraGam is GRAS.

If anyone has evidence to support the claim that EnteraGam received GRAS status independent of the GRAS status granted by the FDA to Immunolin, please present it here. I am learning new things about this everyday and welcome all opportunities to learn more.


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## jstezelecki (Sep 23, 2013)

Cuzi,

Yes I have been in contact with EnteraGam but not about supplements or other copy cat type products. I have recently seen my GI doctor when I picked up some of my samples and discussed about obtaining some generic immuglobins, something that I can afford. I didn't have a long conversation about the matter but it was indicated to me that the product was not available in supplements, OTC or any other form. I was informed that the Orpan Act 316 protects the applicant for 7 years from anyone else marketing the product. I didn't get into anymore specifics with my GI doctor since he was in between patients and pretty tied up. I hope I don't have to wait seven years before I can take the product.

Unless I can have a qualified chemist actually test check the supplements product versus the actual Orphan approved Medical Food, and he or she can tell me it's the same product, to protect myself, I AINT taking it. Also unless proven otherwise, I'm not going to suggest to anyone else that a supplement is the same product as a approved prescription only Medical Food. For me to do so would be irresponsible as well as dangerous. I'm also hoping that Jeffrey would delete any such statements in this forum from anyone who would suggest that a supplement is the same as an approved prescription Medical Food without lab proof. Thank You.

John


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## Moises (May 20, 2000)

John,

You addressed your post to cuzi but its content seems more appropriate to what I posted.

You said that we should avoid irresponsible and dangerous recommendations. I wholeheartedly agree and apologize if anything I said could endanger anyone.

If that is the case, I would hope that Jeffrey would not delete my comments. I think that everyone would benefit by seeing any errors I made. Certainly there might be someone else out there who could have made the same errors that I might have made and that someone would benefit by seeing how you, Jeffrey, or anyone else corrected those errors.

You also said that EnteraGam is an approved prescription medical food. I find that confusing because Jeffrey said that (in post #70 and earlier) EnteraGam is "not approved by the FDA," although it is regulated by the FDA.

So, it appears that it would be wrong to tell anyone that EnteraGam is approved. Or, if it is approved, it is not FDA approved.

But I would hope that Jeffrey keeps your post up even if it is true that EnteraGam is not FDA approved. Other people might be similarly confused.

There is a lot of confusion surrounding this issue. I agree with you that verified lab reports would help clear up some of this confusion. But as we all continue to learn more about this, let us do so in a spirit of open discussion. The whole point of a forum is that we can all learn from each other.

Thanks,

moises


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## Jeffrey Roberts (Apr 15, 1987)

In my discussion with Entera Health, it was my understanding that Xymogen has no agreement with Entera Health's sister company Proliant, to acquire EnteraGam. My understanding is that Xymogen has a very limited supply and the relationship was ended and supply was terminated in order to comply with medical food regulations.

I am not aware of any other similar substance to EnteraGam on the market. I do not believe any are in the correct concentrations, nor are they necessarily in an edible grade.

I'm not sure why anyone would want to put a substance into their body that has not been rigorously made available through a prescription program which also receives pharmacy benefit reimbursement via a co-pay vs. paying cash to someone over the internet for something which has never been studied for an IBS treatment.

We strongly advise talking to your physician about any treatment plan you may undertake.


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## IBS2 (Feb 7, 1999)

Moises,

I certainly don't think you have anything to apologize for. This is a forum and the issues you raised were certainly important enough to be part of the overall discussion dealing with potential alternatives to Enteragam that did not 1. require a visit to the doctor to get a prescription, 2. were less expensive and 3. contained the same active component (Immunolin). I found your logic sound and the fact we're talking about supplements with essentially the same warning regarding allergy to beef, it would seem the potential risk of using the supplement vs Enteragam were quite low and certainly not in the realm of being irresponsible. Assuming we're all adults in this discussion then it would be up to the individual to make an informed decision what they want to consume. I for one appreciate the time and effort you have put into researching this subject.


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## Kathleen M. (Nov 16, 1999)

A lot depends on what risks one is willing to take. And I know a lot of people just can't tolerate the idea of paying for anything that has pharma anywhere near it. So it depends on what is important to you as well.

The medical food being FDA regulated is going to have to prove it contains what it says on a regular basis. One problem with supplements is it is mostly up to them to decide what kind of quality control they think they might need.

I think someon said there was one being sold for body building I would generally steer clear from those as certain types of products (like body building or weight loss) seem more likely than others to be adulterated with what should be prescription medications or herbs that aren't on the label as they often can't get enough of the new hot herb for all the pills they plan to make.

There are some very good supplement companies, but hard to know which is, and I suspect all of the ones in it for the money who can't, or won't, make a quality product will come out of the wood work with their own version of what they say is the same ingredients if Enteragam starts selling well.

I dunno how much variation there is in this kind of product (is it like a probiotic where two strains even of the same species may be different) although at least you hope they can tell a cow from other animals where herbs can be a lot harder if the locals know herb A looks like like the herb B that is both selling like hotcakes and extinct from over collecting in their area.

I dunno that I'd take the "beef allergy" warning as proof they actually used either cow in it, or the right bits of cow. You know you need to put that on if you claim there is beef in there. And we know there has been plenty of horse being sold as beef in some countries so like I said, you hope they can be sure they are using cows.


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## Moises (May 20, 2000)

The FDA maintains an Orphan Drug database here:

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm

When I search for "EnteraGam" no results come up. Has anyone else been able to find more information on this? The database is updated monthly by the FDA and EnteraGam has been a medical food orphan drug since at least February 2013. Any ideas why it is not in the FDA's database?

By the way, there is a relatively pithy, accessible, review of the FDA's medical food designation here:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm

Section 15, under "Questions and Answers," gives a clear explanation of what a medical food is and is not.

Oh, while composing this I see that Jeffrey has an update on the relation between EnteraGam and Proliant. Thanks for providing more information. It provides a few more pieces to the puzzle.


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## IBS2 (Feb 7, 1999)

I just thought I'd post an interesting site comparing the contents and costs for products that contain Immunolin. http://www.extremeimmunity.com/immunolin-cost-comparison


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## Moises (May 20, 2000)

IBS2,

Thanks for posting that.

Here's what I don't understand. Immunolin contains 45% IgG. You can find that here:

http://www.innovadex.com/Food/Detail/4104/114823/ImmunoLin-WP

and many other places.

Here is one product's label confirming that the IgG is 2.25/5, or 45%:

https://www.xymogen.com/products/product-detail.aspx?pid=81

Yet Extreme Immunity claims that it has 14% IgG:

http://www.extremeimmunity.com/about-extreme-immunity

Something doesn't add up. The Extreme Immunity package label shown in your link is not consistent with that 14% IgG claim. The package label shows 49% IgG (2250/4570).

In their cost comparison for Nutritional Science they show that there is more IgG than Immunolin. That is logically possible but highly unlikely in an Immunolin product, because IgG is just one component of Immunolin.

In any case, most of the products shown in the cost comparison are of limited availability or completely unavailable. As Jeffrey suggested, it might be the case that Immunolin is being taken out of the market. As Jeffrey showed, Proliant Health (Immunolin's owner) and Entera Health (EnteraGam's owner) are closely related business entities with some employees being employed at both companies. For example, this job posting:

http://www.linkedin.com/jobs2/view/9507488

describes Proliant Health / Entera Health as a single entity. Of course they are not. They are registered in Iowa as distinct business entities. But they share the same address and some officers in one company are officers in the other.

If you search the internet, you will see numerous reference to immunolin.com. That site no longer exists. If you go to Proliant's website, you will find no mention of Immunolin. So, it appears that Proliant is, at a minimum, removing Immunolin as a presence on the web as its affiliated firm, Entera gears up its marketing campaign for EnteraGam.


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## StacyRN (Dec 9, 2013)

Hyperimmune-immunogloblins are not new in medicine, nor is the use of IgG antibodies in the fight against microorganisms. If you search the generic "bovine immunoglobulin" you will find much research. What is interesting to me is that the research was done on AIDS patients, malnourished children (who are often immuno-compromised) and pigs with toxic e. coli infections in their intestines. So, IF your IBS is CAUSED by microorganisms, this may be an appropriate supplement to try. However, if your symptoms are caused by a food INTOLERANCE, such as Lactose Intolerance or Fructose Intolerance, you are probably lacking an enzyme, not 'infected.' And if your IBS is caused by food SENSITIVITY, such as gluten sensitivity, you don't have an infection and need an external source of IgG (which you probably make plenty of on your own), you would need to avoid gluten. And using these studies to generalize to the IBS-D population as a whole is inappropriate. You may find that your MD will easily give you a presciption for it... why, because nothing else has worked for you and you aren't happy with that, and they are not going to take it, you are.

Be cautious of getting all of your information on this product from data published by the manufacturer or the paid investigators of the company... all meds, even "medical foods" should have research that has been performed by third parties that confirm its safety and efficacy. And really, you WANT MORE HUMAN studies! This is not a pharmaceutical that requires multi-million dollar clinical trials and FDA Approval. It is a commercially available immunoglobulin used in a variety of human supplements.

Here are the studies on which EnteraGam is basing it's claims:

*1.* Asmuth DM, et al. Changes In Stool *Microbiota*, *Bacterial* Translocation and Mucosal Immunity after Oral Serum-Derived *Bovine Immunoglobulin* (SBI) Administration. Poster Presented at: 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA.
*2.* Asmuth DM, Ma Z-M, Albanese A, et al. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in *patients with HIV enteropathy*. AIDS. doi:10.1097/QAD.0b013e328362e54c.
*3.* Lembcke JL, Peerson JM, Brown KH. Acceptability, safety, and digestibility of spray-dried bovine serum added to diets of recovering *malnourished children*. J Pediatr Gastroenterol Nutr. 1997;25(4):381-384.
*4.* Bosi P, Casini L, Finamore A, et al. Spray-dried plasma improves growth performance and reduces inflammatory status of weaned pigs challenged with *enterotoxigenic Escherichia coli *K88. J Anim Sci. 2004;82:1764-72.
*5.* Peace RM, Campbell J, Polo J, et al. Spray-dried porcine plasma influences intestinal barrier function, inflammation, and diarrhea in *weaned pigs*. J Nutr. 2011;141:1312-7.
*6.* Orphan Drug Act. FDA website. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm. Accessed May 8, 2013.


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## StacyRN (Dec 9, 2013)

Serum-derived *Bovine* Immunoglobulin means that they are collecting it from cow's blood.


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## StacyRN (Dec 9, 2013)

to FLITWIT: Are you under the care of a physician? Does your physician know you've gone from 183 to 90+ pounds. I don't know what your height is or how quickly you lost the weight but, that is truly concerning. There is a medical food called Vivonex (tastes terrible), that is medical food broken down into simple amino acids, etc so the gut can absorb easily, quickly, and without allergic or sensitivity reaction. It can be administered via naso-gastric tube so you don't have to taste it. I tried drinking it once, and after one try, I could never get the cup up to my mouth again.


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## Moises (May 20, 2000)

StacyRN said:


> So, IF your IBS is CAUSED by microorganisms, this may be an appropriate supplement to try. However, if your symptoms are caused by a food INTOLERANCE, such as Lactose Intolerance or Fructose Intolerance, you are probably lacking an enzyme, not 'infected.' And if your IBS is caused by food SENSITIVITY, such as gluten sensitivity, you don't have an infection and need an external source of IgG (which you probably make plenty of on your own), you would need to avoid gluten. And using these studies to generalize to the IBS-D population as a whole is inappropriate. You may find that your MD will easily give you a presciption for it... why, because nothing else has worked for you and you aren't happy with that, and they are not going to take it, you are.
> 
> Here are the studies on which EnteraGam is basing it's claims:
> 
> ...


StacyRN;

Thanks for contributing your research to this thread.

Please correct me, but here is the argument I understand you to be making:

1. IBS can be caused by microbes in some patients.

2. IBS can be caused by food intolerances or sensitivities in some patients.

3. EnteraGam has only been demonstrated to help mammals with microbial problems.

4. Therefore, EnteraGam is inappropriate to administer to those with IBS caused by food intolerances or sensitivities.

Statement 3, above, is not accurate. One of the studies EnteraGam uses to support its efficacy is this:

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&cad=rja&ved=0CEYQFjAE&url=http%3A%2F%2Fwww.la-press.com%2Fredirect_file.php%3FfileId%3D5355%26filename%3D3990-CGast-Evaluation-of-Serum-Derived-Bovine-Immunoglobulin-Protein-Isolate-in-S.pdf%26fileType%3Dpdf&ei=u7WlUpCLMqrKsQTFnoHQBg&usg=AFQjCNEex9cKdhT_sgvqSC-Nn2XnbxrbpQ&sig2=m3LzmPubZkJJ3TADR7PKBw&bvm=bv.57752919,d.cWc

These were human patients with IBS-D using Rome II (page 50). No specifically microbial criteria were used for admission into the study's population.

The study was supported by EnteraHealth, which is a legitimate criticism. But this stuff has been used in human beings for more than a decade and there are no reports of harm. So, I am having trouble understanding why it wouldn't make sense for people with IBS-D to give this a try. If it works, great. If it doesn't work, they are out a few bucks and they can cross another thing off their list.

---------------

According to Wikipedia:

http://en.wikipedia.org/wiki/Libertas_Academica

the publisher of the research article that I linked to, above, uses a peer-review process sufficiently rigorous that it catches and rejects obviously flawed research.


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## Moises (May 20, 2000)

http://www.enterahealth.com/news/ceo-dr-gerald-klein-discusses-o-launch-their-enteragam-bovine-serum-derived-immunoglobulinprotein-isolate-into-the-medical-food-market-for-the-management-of-chronic-gastrointestinal-disorders

The link, above (from the Entera Health website), will take you to an interview with the CEO of the manufacturer of EnteraGam.

Here are some tidbits:

1. The EnteraGam product has been used in animal husbandry for over 20 years.

2. About 200,000 people "used this food product" before the launch of EnteraGam. That is, they used it as a supplement, because it was not yet available as a medical food.

3. Among those 200,000 supplement users, none sent reports of "serious adverse events" to the manufacturer.

4. The differences between the supplement and the medical food are:

a. the medical food has a higher potency than the supplement

b. the medical food is targeted at "people with specific medical problems," while the supplement is for "healthy people."

Point 4a confirms Jeffrey's post that EnteraGam had a different concentration than previous products. We now know, more specifically, that EnteraGam has a greater concentration than the supplement. But we do not know how much more concentrated it is.

---------------------------

After writing the above, I found that a lot of the information I've been searching for these last few days was hiding in plain sight on the ibsgroup.org site:

http://www.ibsgroup.org/forums/topic/168061-i-started-enteragam-nov-132013/?p=906949

Here is a November 19 message that a forum member, pielala, received from her (his?) physician:

Here's some new scoop for you on the IgG thing...

Proliant, the company who had the "exclusive" distribution

contract with Xymogen for Ig, formed new company, Entera Health,

in order to package same product into "medical food" and

market it to doctors so they could make more money. They

registered it with the FDA, which is not the same as FDA

approval. Last week they made the decision to break

contract with Xymogen because they weren't making the

money they anticipated with newly packaged Enteragam.

The strategy is that if they can stop production through

Nutrition companies then doctors will be forced to use

their product. Xymogen already has a new supplier

and will be ready with new formula by the new year.

So, you knew first, then told me, then my rep knew a day

before the Xymogen owners and directors conferenced on

the topic and explained what had happened...

Total craziness.

Fortunately I (and my patients) will not be left in the lurch...

Sorry Enteragam did not work out for you. We'll see how you

feel being off of it for a bit.

I cannot vouch for the accuracy of this. I post this merely to make the information more accessible.

If the information is true, it suggests why there has been so much confusion. It would appear that Immunolin and EnteraGam were coexisting, one as a supplement and the other as a medical food, until some time in mid-November 2013 when Entera/Proliant made the decision to stop supplying the supplement industry.

This suggests that some of the discussion on supplement companies versus pharmaceutical companies was not quite on the mark. In this case, and many others, the supplement company was the pharmaceutical company. This arrangement is not that unusual.

pielala's post suggests that there are other manufacturers of SBI in the US. That is news to me. I can't imagine that any of them have the experience that Proliant had, but lots of things that I can't imagine end up being true.


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## PD85 (Aug 19, 2010)

Moises said:


> http://www.enterahealth.com/news/ceo-dr-gerald-klein-discusses-o-launch-their-enteragam-bovine-serum-derived-immunoglobulinprotein-isolate-into-the-medical-food-market-for-the-management-of-chronic-gastrointestinal-disorders
> 
> The link, above (from the Entera Health website), will take you to an interview with the CEO of the manufacturer of EnteraGam.
> 
> ...


So does this mean that whatever Xymogen I can still purchase from left-over stock, etc., would be the EnteraGam SBI just at a lower concentrate/dosage?


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## HNat (Apr 7, 2012)

Moises - that's an insane amount of research and detective work!! I think what you said makes sense. Not sure about Jeff and Kathleen - they seem to be marketing enteragam. I wonder if Enteragam is planning to buy this website


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## Kathleen M. (Nov 16, 1999)

Usually if a company has something new they tend to be who is buying the ad space on the site that it takes to keep it running.

You'll find that whenever someone has something new rolling out they tend to be the ones with the ads here (and other places).

I have no stake in the company, other than I want any company that is making good quality products, especially ones that may be able to mount an education about IBS campaign to the medical field (which desparately needs it in a lot of cases) to do well. The more that do well (and don't get immediately unapproved by the FDA, or severely restricted) the more companies will be involved in research and development for IBS targetted treatments.

I, personally, don't see the big difference between a company being in "big pharma" going the FDA route and doing whatever they need to do to make a profit and a supplement company avoiding the FDA regulatory apparatus and doing whatever they need to do (and some of them do some pretty shady things since they don't have to answer to the FDA about much of anything unless they start killing off a bunch of people or get caught adding illegal prescription medications to their products) to make a profit.

But I understand some people don't want anything to do with anything that sounds like a big pharma product or that is regulated by the FDA. I just don't understand why if it is on the supplement aisle people assume no one is in it for the money at all and none of their employees want competative wages, or benefits, and the CEO lives in a van down by the river.


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## Moises (May 20, 2000)

I really wanted to avoid turning this thread into a political debate but it seems that it cannot be avoided.

This site provides a valuable service to those of us who have IBS. It costs a lot of money to maintain this valuable site. Most members of this site make no financial contribution to it.

It is reasonable for the owners of this site to seek alternative sources of funding. Pharmaceutical companies can provide alternative sources of funding. It is reasonable for the owners of this site to obtain funding by allowing corporations to market their goods to members.

No administrator of this site has acted in a heavy-handed way to limit this discussion. I applaud them for that. There was a call by a member to limit the discussion and the administrators' mature response was to ignore it.

So, this board needs to be funded somehow. I do not object to corporate funding of this board as long as members are permitted to express (politely and civilly) dissenting opinions. I believe that this thread is a model of openness and free exchange. Jeffrey and Kathleen expressed themselves but never even hinted that those with differing views (e.g., me!) should tone down their opinions.

As to the larger question of whether it is evil for Proliant/Entera to shut down Immunolin and focus on EnteraGam, I come down on the side that it is not evil.

Immunolin has been available for more than a decade. A few days ago I revived a thread from 2002 on Immunolin. Why did discussion (and, presumably, use) of Immunolin decliine to virtually nil? Because the only thing supporting its use was a couple of anecdotes.

Flash forward to today. Why are so many excited by SBI? Because clinical studies have been published in peer-reviewed journals. These studies are expensive and some people in some corporation decided that they could only justify the expense of these studies if the potential financial reward was higher than that available through the distribution of supplements. It seems to me that they made a reasonable decision and we have all benefited from the new knowledge that we have gained from these clinical studies.

If the message from pielala's physician is to be believed there are other makers of SBI. If there is a demand for SBI as a supplement, rather than a medical food, those other manufacturers might be able to fill the void left by the disappearance of Immunolin. If the quality of those other SBI products is problematic, each of us is free to choose EnteraGam instead.

In summary, I am grateful that Jeffrey and Kathleen made me aware of SBI and provided me with a forum to exchange my ideas freely with others. And I am grateful that Proliant/Entera did the research suggesting SBI can significantly improve symptoms in subjects with IBS-D.


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## Kathleen M. (Nov 16, 1999)

There have been other products with various sorts of who owns what formula and who shut down whom and all that before on this site.

As long as the businesses keep whatever internal conflicts, changes, transformations and changes in directions within their own company, I really don't mind as usually it is just part of doing business and sometimes they do change business models and that means something go away and other things come to the forefront, or partnerships dissolve and each party gets some portion of the old business, etc.

Just as long as they don't start joining here and pretending they have IBS and try to use this forum as a way to get in personal attacks against the spin offs or who got what in the divorce (so much fun when life partners are business partners and it goes south). We did have to intervene in one battle of whose product was better because it became obvious it was people from the companies trying to wage war on each other not people with IBS discussing which of similar products they may be deciding between and discussing why one product may be similar, better, or worse than other products.


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## Jeffrey Roberts (Apr 15, 1987)

I can assure you that Entera Health is not buying this website.

I believe we are very transparent about advertisements that you see sprinkled around the website. EnteraGam falls under the same guidelines and is no different than any other product that we want to share with IBS sufferers through advertising so that you can discuss them with your own healthcare provider.

This is from our About Us page:



> The IBS Self Help and Support Group website is privately held by MediBoard Inc., a for-profit company (with a not-just-for-profit attitude). Every partnership we develop must bring us closer to aligning patient and industry interests. Our end goal is to improve patient care and quality of life. Funding for IBSGroup.org is obtained primarily from the sale of advertising space. Our website hosts advertisement banners and sponsored links. Advertisement is distinguished by the word "Advertisement". Some funding to develop content is provided in the form of an unrestricted educational grant and content which was written under a grant, is labeled as such. Where content of our website has been used with permission, it is cited as such.
> 
> ...
> 
> Revenues from advertising and affiliation go directly to funding the activities of IBSGroup.org. Advertising and affiliation do not dictate editorial content. There is no implied endorsement of any sponsored product advertised on/through the IBSGroup.org website.


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## IBS2 (Feb 7, 1999)

Just some thoughts. First, while I don't mind the site being supported by ad revenue, I do however believe the site has the responsibility to display those advertisements in a responsible way. For instance, the other day there was an add claiming to cure IBS in 4 days. If this was the truth within a week or two there would be no need for this forum and we all know that ain't going to happen soon. Anyone who has been a regular reader of this forum has seen the claims of miracle cures to end the misery of IBS and it borders on cruel to promote such a product without significant clinical evidence of improvement.

On Enteragam, the overall discussion has been very informative and I thank Moises for the amount of research completed. With regard to Enteragam's corporate behavior I too believe that a company is entitled to a decent return on investment. That said it would be interesting to know what the cost of production is versus the market price of almost 400 dollars per month.


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## PD85 (Aug 19, 2010)

Moises do you have the answer to this question?



PD85 said:


> So does this mean that whatever Xymogen I can still purchase from left-over stock, etc., would be the EnteraGam SBI just at a lower concentrate/dosage?


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## HNat (Apr 7, 2012)

@Jeff and Kathleen - Sorry I didn't really mean it in a bad way. Fact is that I (we all) truly appreciate your work and how you both manage this site which has made all our lives so much better...If you do eventually make $$ by selling the site, then you deserve it!!


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## Jeffrey Roberts (Apr 15, 1987)

IBS2 - depending on where you are located in the world, you are seeing different banner ads. Most of the ads are filled by Google Adsense ads and they are geographically filled based on your location. We actually have very limited control over what is being served by Google; however, when we do find an offending ad in the Google stream we can try and block them. If you pass on the URL of any offending ad, we can investigate blocking them.

This thread has really taken on a weird tone.

Personally, I would pay anything for access to a treatment that may work. I wouldn't be searching for the cheapest price. Why don't you all just talk to your physicians about trying EnteraGam and see if it works for you before trying to source it cheaper. Funny - we don't usually see this with other prescription medications.


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## jstezelecki (Sep 23, 2013)

I'm not aware of what the Xymogen dosage is or if it's still available as left over stock anywhere but it should be noted that the single package per day starting dosage for EnteraGam may not be enough to resolve some individuals IBS issues. According to the EnteraGam packaging directions, it indicates that it could take up to four packages per day before seeing acceptable results. If indeed the Xymogen supplement is available and is indeed a much lower dosage than a single pack of EnterGam, it may require a significant amount of the product before seeing positive results.

John S.


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## Moises (May 20, 2000)

> So does this mean that whatever Xymogen I can still purchase from left-over stock, etc., would be the EnteraGam SBI just at a lower concentrate/dosage?


Yes. The published interview with the Entera Health CEO provides strong support for the conclusion that Xymogen IgG 2000 DF and Now Foods Immune Advantage, that have "Immunolin" on the label, contain the same active ingredient that EnteraGam contains but at a lower concentration. [Correction: Xymogen does not state "Immunolin" on the label. I have no idea if they will change the label if they choose to make the product with an alternate source of SBI.]

How much lower is not known (by me). It is odd, but I am unable to find any published analysis of EnteraGam. There are many published analyses of Immunolin.

In this (apparently unpublished) study:

http://m.newhope360.com/supply-news-amp-analysis/immunolin-improves-quality-life-new-ibs-study

Eric Weaver, the main author of the main EnteraGam clinical trial on IBS-D, used 10 gram/day of Immunolin.

Here is a selected quotation:



> Researchers recruited 33 females and 18 males-the disorder is more prevalent in women-aged 40 to 55 with diarrhea-predominant IBS. During the six-week double-blind study, subjects randomly received one of three treatments: 10 gm of ImmunoLin, 10 gm of soy protein, or a combination of 5 gm of ImmunoLin and 5 gm of soy protein, in 20 capsules per day taken five at a time. Overall days with symptoms decreased by 16% and 18% in the 5 gm ImmunoLin and 10 gm ImmunoLin groups, respectively, compared to the soy protein control group.
> 
> From the 4th through the 6th weeks, overall days with symptoms decreased by 24% in the 10 gm Immunolin group compared to the soy control group. Noting this acceleration in quality-of-life, Proliant lead researcher Eric Weaver, PhD, observed, "We may need to do a longer study because results were improving as the study progressed.


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## IBS2 (Feb 7, 1999)

Jeff,

I believe the reason for the discussion on Enteragam is because I can't think of an IBS medication that's available in both prescription and non prescription at the same time. I'm sure most of us would pay a king's ransom for a cure, but for many the cost of medication is a problem when you're trying to pay all the other bills. That said, if the research posted in a prior post showing a symptom decrease of 18 percent at best leaves one to judge if the cost is worth the benefit, since we're not talking cure here. I'm glad it's available and look forward to seeing how people respond to Enteragam.


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## Moises (May 20, 2000)

A Comparison of the Composition of Immunolin and EnteraGam

This is a newly published journal article from Entera Health:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3819310/

EnteraGam is:



> over 90% protein (by weight), with over 50% of the protein consisting of immunoglobulins (Ig), mainly IgG


I have previously posted this link:

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=6&cad=rja&ved=0CE0QFjAF&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Ffcn%2Fgras_notices%2F710670A.PDF&ei=IC6qUqShBtWysQSk2YDgAg&usg=AFQjCNG0tCySHFfVNTVqekhJNbWcvUp8NA&sig2=1NEPtzN91ahUwIVefV3udg&bvm=bv.57967247,d.cWc

which includes the Immunolin FDA documents.

The Immunolin Adobe file has 130 pages. On page 24 we find that Immunolin has:

1. >= 90% protein, which is the same as EnteraGam.

2. 64% (59/92) of the protein from the immunoglobulin IgG, IgA, and IgM. This meets or exceeds the EnteraGam immunoglobulin content.

3. 59% (54/92) of the protein is IgG. This meets or exceeds the EnteraGam IgG content.

The FDA documents make clear that the production process entails some variation in content with each batch. So the analysis of any particular batch could differ from that of another.

Given these two documents it appears that EnteraGam and Immunolin have substantially identical contents (before accounting for the dextrose [sugar] added to EnteraGam.

That makes me wonder why the CEO of Entera Health claimed that EnteraGam's concentration is higher than Immunolin and why Jeffrey was told by Entera Health that the concentrations of the two products differ.

In any case, if you purchase a supplement form of SBI, you can read the label. You can then compare that label to the EnteraGam contents given in the November 2013 journal article. If there is any difference, you can adjust your dose accordingly.


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## PD85 (Aug 19, 2010)

I have begun taking a product called Bio-Gro.

http://www.bodybuilding.com/store/isatori/bio-gro.html

It is meant for bodybuilding but maybe it would have some IBS results as well. I am taking it at 4 scoops per day so that's 6g of the concentrate. Will post results if I see any.


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## JonSnow (Dec 9, 2013)

Enteragam is covered under Anthem BCBS.

My copay is $25 per month.

With the $75 voucher it's free.

My pharmacist thinks I can use the voucher repeatedly, for up to 1 year (i.e. free EnteraGAm for a year) but wasn't 100% sure.

I've used the voucher twice so far.


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## Moises (May 20, 2000)

Thanks for the update. That is good news.


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## jstezelecki (Sep 23, 2013)

Jonsnow,

I'm thrilled that your BCBS is covering the medical food. I wish my Ma. BCBS would come around and cover it. I think that if my BCBS covered it, I would get a four a day prescription and obtain a 90 day supply with just one co pay.

My sample count is growing so I'll start taking EnterGam soon. Thanks for the info.


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## legbuh (Jan 9, 2005)

I've been drinking Kefir and home made Kombucha. It's done more for me than anything. And you don't need an RX for it!

Having been through making home made Kefir (yuk!) to water kefir (its ok) to kombucha.... I say buy the lifeway kefir and make your own 'buch and drink a couple ounces of each after every meal. works pretty good along with Imodium (just in case). The KT (kombucha tea) has the best benefits but the kefir does add to it.

they provide natural probiotics that help digest foods our guts don't like. But the only problem is they don't multiply and stick around. Which means yes... fecal transplants are probably the way of the future for those of us who's flora has been destroyed. But these things (as well as other naturally fermented foods) are what we are missing in our diet these days.


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## wumonty (Jan 10, 2008)

anyone know where i can get xymogen 2000df? the manufacturer themselves says it back ordered for unknown time frame..

how about immunolin?


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## treyevans (Nov 20, 2014)

Any further development into this? I am asking because:

1. I began taking a sample pack of EnteraGam and immediately began feeling relief from months-lasting constipation due to Crohn's

2. While my health coverage will most likely cover EnteraGam, I follow a paleo diet and I am not happy at all about consuming 5grams/dextrose daily indefinitely.

3. I am interested in an alternative to EnteraGam in a more pure form and without the additives.

4. I am confused by the different ingredient names between SBI, SBA (bovine serum albumin), IgG (Immunoglobulin G) ... are these the same active ingredient?

Any direction towards the best alternative to EnteraGam would be greatly appreciated.

Thanks,

Trey


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## Browndriver (Jun 25, 2018)

I know Im late to this discussion but I have IBS-C and Enteragam did help me and insurance was not going to pay enough for it to be feasible for me to continue so was looking for a alternative and I found IgG Plus form Extreme Immunity. Any thoughts looks the same at a fraction of cost.

Dave


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