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RNIB21 in IBS-D
NCT06727422Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- Aug 2026
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Irritable bowel syndrome with diarrhea (IBS-D)
01
Overview
Phase 2, randomised, double-blind trial of rifaximin + N-acetylcysteine in Irritable bowel syndrome with diarrhea (IBS-D) (3 arms). Primary endpoints: Stool consistency at 2 weeks and Abdominal pain at 2 weeks. Started Feb 2026; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
low dose for IBS-D
RNIB21 containing rifaximin 66mg + NAC 560mg TID
high dose for IBS-D
RNIB21 containing rifaximin 132mg + NAC 560mg TID
placebo
Placebo TID
03
Who it enrols
Adults with Rome IV confirmed IBS-D with inadequate symptom relief, moderate to severe abdominal pain, and loose stools, excluding those with other GI diseases, recent antibiotic use, asthma, or significant medical conditions.
04
Endpoints
Primary
Stool consistency
Abdominal pain
Secondary
Overall response
Stool frequency
Stool image via smartphone app
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