What is the Purpose of this Study?
The purpose of this study is to determine whether an investigational drug called RNIB21 can effectively relieve the symptoms of patients with irritable bowel syndrome with diarrhea (IBS-D). RNIB21 is a capsule that combines an antibiotic (rifaximin) with a drug that breaks up mucus (N-acetyl-L-cysteine, “NAC”). NAC may help to make rifaximin work better in the body. The small intestine contains thick mucus; researchers aim to learn whether NAC can break up this mucus layer and potentially increase the effectiveness of rifaximin. The study will be test 2 doses to determine which dose is most effective. Procedures include providing urine and blood samples, completion of surveys, and taking medication.
Eligibility
- 1. Male or non-pregnant, non-lactating female patients ≥ 18 years of age
- 2. Diagnosed with IBS confirmed by the Rome IV criteria, with associated symptoms of diarrhea as noted below in 4(b).
- 3. Do not have adequate relief of IBS symptoms of abdominal pain, stool consistency or stool frequency
- 4. Have daily IBS symptom scores during screening as below:
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety, Efficacy and Pharmacokinetics of RNIB21 in the Treatment of Patients with Irritable Bowel Syndrome with Diarrhea