Rifaximin for the Treatment of Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborators: Bausch Health Americas, Inc.; University of Chicago; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Subjects will be selected for all studies based on the Rome I criteria. This will be the preferred method of identifying IBS patients to avoid pre-selecting patients with C- IBS. The goal is to evaluate methane as the determinant of transit, not constipation or diarrhea symptoms as through Rome II criteria. All subjects who are receiving a prokinetic drug at the time of enrollment will need to have a washout period of 7 days before starting the study protocol. Subjects will be identified through advertising in printed media and through the clinical operations of the GI motility program at Cedars-Sinai Medical Center.

Exclusion Criteria:

• Subjects with a history of inflammatory bowel disease, diabetes, previous intestinal surgery, cirrhosis, celiac disease, probiotic use, current proton pump inhibitor use, recent antibiotic use (past 3 months), history of bowel obstruction, narcotic use or age greater than 65 years will be excluded. Most of these conditions are known to influence enteric bacteria levels. Women of childbearing years will undergo pregnancy testing before participating in the study (See below for details on the pregnancy test used). Women with positive pregnancy tests will be excluded.