# Clinical Study Confirms PROBACTRIX(TM) Highly Promising for IBS Symptoms



## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/prnews/030611/nyw027_1.html Clinical Study Confirms PROBACTRIX(tm) Highly Promising for IBS SymptomsWednesday June 11, 8:30 am ET Randomized, Double Blind Study Finds BioBalance's Medical Food Relieves Major Symptoms in Both Men and Women, With No Side Effects Seen NEW YORK, June 11 /PRNewswire-FirstCall/ -- Patients with severe symptoms of irritable bowel syndrome (IBS) experienced significant improvement of their complaints in a randomized, double-blind, placebo-controlled study of (PROBACTRIX(tm)), a probiotic oral suspension from The BioBalance Corp, a wholly owned subsidiary of New York Health Care, Inc. (Nasdaq: BBAL - News), the company reported today.PROBACTRIX(tm) is a patented and proprietary formulation of M-17 E. coli which is approved as an OTC pharmaceutical in Russia and as a food supplement in Israel. BioBalance intends to comply with United States Food and Drug Administration requirements for the eventual introduction of PROBACTRIX(tm) to the United States market as a medical food.The randomized, double blinded study involved 20 IBS patients (N=20, mean age, 46 years), experiencing severe symptoms of diarrhea and constipation with a mean duration of eight years. All patients in the study validated medical criteria (ROME II) for IBS, and had had both general medical and gastrointestinal evaluation including negative colonoscopy within past 5 years. The group included both men and women. Patients received either placebo or PROBACTRIX(tm) for a month and then crossed over. Drs. Elisa Tiomny, Revital Kariv, Zamir Halpern, at the Department of Gastroenterology, Tel-Aviv Medical Center, Tel-Aviv, conducted the study.Study ResultsEight of 10 patients that started on placebo dropped out because of infectivity, as opposed to 10 patients who started on PROBACTRIX(tm) and all completed the study. In the treatment arm there was significant improvement in bowel movement (p .lt. 0.01) and mucus in stools (p .lt. 0.051) and borderline improvement in effort during evacuation (p .lt. 0.037). No side effects were seen on ProBactrix(tm)."This pilot study provides further compelling evidence that probiotic approach-and PROBACTRIX(tm) in particular -- may prove to be an important addition to the medical armamentarium for patients with these painful, embarrassing symptoms," said Dr. Samuel Adler, head of the BioBalance Medical Advisory Board. "The patients need the help and we anticipate future trials will sustain the benefits of this approach."Pilot Study Follows Results Presented At Major May 2003 Scientific MeetingA study presented at the 2003 Annual Meeting of the American Society of Gastroenterologists reported capsule endoscopy (CE) results in six of eight intestinal bowel disease (IBD) patients who completed four to six week PROBACTRIX(tm) therapy. Three out of six patients had a very significant clinical response, with marked reduction in abdominal symptoms and improvement in well being. In these three patients, CE revealed significant inflammation in the proximal small bowel pre-treatment and significant improvement post-treatment, according to researchers. Gastroenterologists at Bikur Cholim Hospital, Jerusalem, who presented the initial study.Background on IBS and IBDIBS is the most common chronic gastrointestinal condition, affecting up to 58 million Americans or 20% of the adult population. Symptoms range from constipation to diarrhea and are often accompanied by abdominal pain and bloating. While IBS is responsible for half of the patient visits to gastroenterologists, only 20-30% of sufferers seek medical attention, thought to be due to the lack of effective treatment options available.IBD refers to two specific types of disease: Crohn's Disease and ulcerative colitis. Both of these diseases have different forms and are estimated to afflict more than one million Americans. Crohn's disease and ulcerative colitis are chronic digestive disorders. Their cause is unknown. Ulcerative colitis inflames the inner lining of the colon (large intestine) and the rectum. Crohn's disease may affect the lower part of the small intestine, the colon, and other parts of the digestive tract.The BioBalance CorporationBioBalance is a development stage company, whose business is the discovery, manufacturing and marketing of probiotic agents and ethical drugs for therapy of gastrointestinal (GI) diseases. The science of probiotics is the utilization of live microbial agents to benefit an animal or human host by improving intestinal microbial balance through the stimulation of the growth of healthy bacteria and thereby restoring the microbial balance. On January 2, 2003 The BioBalance Corp., in a Stock Exchange Agreement, merged with a wholly-owned subsidiary of New York Health Care, Inc. ("NYHC"), a publicly traded company engaged in providing home health care services.SAFE HARBOR STATEMENT In addition to historical information, certain of the statements in the preceding paragraphs, particularly those anticipating future events, financial performance, business prospects and growth and operating strategies constitute forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as anticipate, believe, estimate, expect, intend, predict, hope or similar expressions. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements, including, without limitation, satisfaction of approvals and conditions applicable to the transaction described above, the company's ability to implement its strategies and achieve its objectives and the risks and uncertainties described in reports filed by the company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation, cautionary statements made in the company's 2002 Annual Report on Form 10-K, the company's Form S-4 Registration Statement, its latest quarterly report on Form 10-Q and current reports on Form 8-K. --------------------------------------------------------------------------------Source: BioBalance Corporation


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## SteveE (Jan 7, 1999)

This is interesting since the Great Smokies test which I have frequently complained is of no use because of limited tools to apply to their results indicated that I had lower-than-normal levels of E. Coli. That struck me as odd at the time since there were all sorts of news broadcasts about E. Coli contamination of deli food, ground beef, etc.


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