Phase 2
N=45
Efficacy and Safety of Rifaximin With NAC in IBS-D
Irritable Bowel Syndrome With Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT04557215 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Stool Form — -0.26; -0.45; -0.49 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rifaximin (Drug); N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stool Form |
-0.26; -0.45; -0.49 | — |
| PRIMARY Change in Abdominal Pain |
-5.43; -8.90; -5.59 | — |
| PRIMARY Change in Stool Frequency |
-0.04; -0.50; -0.24 | — |
Summary
Randomized, prospective proof of concept, double-blind, single site clinical trial to determine the efficacy of combined rifaximin and N-acetylcysteine (NAC) therapy vs. rifaximin alone in decreasing clinical symptoms in subjects with IBS-D.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged 18-75 years old inclusive
- Onset of clinical symptoms for IBS-D occurring at least 6 months and, in order to progress to treatment phase, meet the following:
- Has abdominal pain, on average, ≥1 day per week in previous 3 months, associated with ≥2 of the following: (1) Related to defecation, (2) Associated with a change in stool frequency, or (3) Associated with a change in form (appearance) of stool.
- Fits Rome IV criteria for IBS with diarrhea (IBS-D), which is defined by >25% of abnormal bowel movements with Bristol stool form types 6 or 7 (loose, watery stool) and 1 year) will not be considered "females of childbearing potential".
Exclusion Criteria
- Use of any oral antibiotics in the last two months
- Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
- Subjects with known pelvic floor dysfunction
- Pregnancy
- Nursing mothers
- Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
- History of bowel obstruction
- History of inflammatory bowel disease or celiac disease
- History of HIV
- Cirrhosis
- IBS-C/chronic idiopathic constipation
- Poorly controlled diabetes or thyroid disease
Data sourced from ClinicalTrials.gov (NCT04557215). 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.