# Research Study: Probiotic Combination (VSL#3) in IBS-D



## Jeffrey Roberts (Apr 15, 1987)

http://www.clinicaltrials.gov/ct/gui/show/NCT00179582Dose Ranging Study with the Probiotic Combination (VSL#3) in Diarrhea IBSThis study is currently recruiting patients.Verified by Beth Israel Deaconess Medical Center September 2005Sponsored by: Beth Israel Deaconess Medical Center Information provided by: Beth Israel Deaconess Medical Center ClinicalTrials.gov Identifier: NCT00179582 Purpose To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBSCondition Intervention IBS Drug: VSL#3 Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study Official Title: A Randomized, Multi-Center, Double-Blind, Placebo Controlled, Dose Ranging Study with VSL#3 in Diarrhea Predominant IBS PatientsFurther Study Details: Primary Outcomes: Global improvement in IBS symptomsSecondary Outcomes: Frequency of bowel movements; Changes in abdominal pain; Changes in bloatingExpected Total Enrollment: 180 The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both CriteriaInclusion Criteria:IBS diarrhea Exclusion Criteria:< 18 years of age Pregnancy/breast feeding concomitant medications to reduce bowel function Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00179582 Kate Bills 617-667-2138 Massachusetts BIDMC, Boston, Massachusetts, 02215, United States; Recruiting Anthony Lembo, Principal InvestigatorStudy chairs or principal investigators Anthony Lembo, MD, Principal Investigator, Beth Israel Deaconess Medical Center More Information Publications that report results of this study Niv E, Naftali T, Hallak R, Vaisman N. The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome-a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Jul 26; [Epub ahead of print]Study ID Numbers: 2004P-000001; VSL1Last Updated: September 15, 2005Record first received: September 13, 2005ClinicalTrials.gov Identifier: NCT00179582Health Authority: United States: Institutional Review BoardClinicalTrials.gov processed this record on 2005-11-18


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