Restoring intestinal symbiosis for efficacy in IBS (RISE IBS-C)
Research type
Research Study
Full title
A Phase 2b, Randomised, Double-blind, Placebo Controlled Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered Full-Spectrum Microbiome Therapeutic (EBX-102-02) in Participants with Moderate to Severe Irritable Bowel Syndrome with Constipation
IRAS ID
1012072
Contact name
Shinofa Rizan
Contact email
Sponsor organisation
EnteroBiotix Limited
ISRCTN Number
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Research summary
This study is testing a drug called EBX-102-02, which is being developed for people with Irritable Bowel Syndrome with constipation (IBS-C). The treatment is based on the principles of Faecal Microbiota Transplantation (FMT), a medical approach that uses healthy gut bacteria from carefully screened donors to restore balance in the gut microbiome. FMT has shown promise across a range of gut conditions and may benefit people with IBS, where evidence suggests that changes in the gut microbiome play an important role in causing symptoms.
EBX-102-02 is a microbiome therapeutic, containing dried gut bacteria derived from pooled, rigorously screened stool samples from healthy donors. EBX-102-02 is delivered as an oral capsule. Each dose consists of eight capsules that contain an off-white, odourless powder.
IBS affects up to 21% of the population and can have a significant impact on quality of life. While the exact cause of IBS is not fully understood, research indicates that disruptions in the gut microbiome may contribute. By helping to restore diversity in the gut microbiome, the treatment may relieve symptoms and improve gut function.
Approximately 200 adults with IBS-C will take part in this study in the UK and US. Participants will be randomly assigned to receive either EBX-102-02 or a placebo. The study will last for 17 weeks, during which participants will attend six visits. At four visits, they will take a single dose of eight capsules. Neither the participants nor the study team will know who is receiving the study drug or the placebo.
During the study, participants will be asked to complete diaries to track bowel habits and report any side effects. At each visit, the study team will review symptoms, assess overall health, and carry out a physical examination. Participants will be asked to provide stool samples at several points during the study, so researchers can track changes in the microbiome and monitor safety.REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0468
Date of REC Opinion
31 Jul 2025
REC opinion
Further Information Favourable Opinion