Phase 3
Completed N=2,583
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
Source: ClinicalTrials.gov NCT01543178 ↗Enrolled (actual)
2,583
Serious AEs
1.1%
Results posted
Jul 2015
Primary outcomePrimary: Repeat Treatment Responders — 32.6; 25.0 percentage of patients — p=0.0232
Summary
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Repeat Treatment Responders |
32.6; 25.0 | 0.0232 sig |
Eligibility Criteria
Inclusion Criteria
- IBS confirmed by Rome III diagnostic criteria.
- At least 18 years of age.
- Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if 10 years prior.
- Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.
Exclusion Criteria
- Diabetes (Type 1 or 2).
- Lactose intolerance and not controlled by a lactose-free diet.
- Pregnant or planning to become pregnant or is lactating.
- History of HIV or hepatitis B or C.
- Participation in investigational study within past 30 days.
- Taking rifaximin or any other antibiotic within past 60 days.
- Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.
- History of GI surgery.
Data sourced from ClinicalTrials.gov (NCT01543178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.