Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Cedars-Sinai Medical Center University of Chicago Salix Pharmaceuticals |
---|---|
Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00259155 |
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.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Drug: Rifaximin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Rifaximin in the Treatment of Small Intestinal Bacterial Overgrowth and IBS: Double Blind Randomized Controlled Trial (Multicenter Trial) |
Estimated Enrollment: | 92 |
Study Start Date: | July 2003 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 4166 |
Study First Received: | November 25, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00259155 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Irritable bowel syndrome, Bacterial overgrowth |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome |
Rifaximin Intestinal Diseases Colonic Diseases, Functional |
Anti-Infective Agents Disease Gastrointestinal Diseases Colonic Diseases Gastrointestinal Agents Intestinal Diseases Pharmacologic Actions |
Digestive System Diseases Pathologic Processes Syndrome Therapeutic Uses Irritable Bowel Syndrome Rifaximin Colonic Diseases, Functional |