Status:
COMPLETED
Rifaximin for the Treatment of Irritable Bowel Syndrome
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
University of Chicago
Bausch Health Americas, Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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. ...
Detailed Description
1. Rome I criteria positive IBS subjects will be enrolled in the study after inclusion and exclusion criteria (see below for description of inclusion and exclusion criteria) are applied. There will be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00259155
Start Date
July 1 2003
End Date
January 1 2007
Last Update
March 18 2008
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