COMPOSER-1
Research type
Research Study
Full title
A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients with Active, Mild-to-Moderate Ulcerative Colitis (COMPOSER-1)
IRAS ID
1009889
Contact name
Claire Birrell
Contact email
Sponsor organisation
Microbiotica Limited
Eudract number
2023-507376-50
Clinicaltrials.gov Identifier
Research summary
The gut microbiome, the community of bacteria in the gut, plays a crucial role in digesting food and protecting people from infections. There is increasing evidence that the gut microbiome may also influence the way the immune system works. Ulcerative Colitis (UC) is an inflammatory condition affecting the colon and rectum, caused by immune system dysfunction. The gut microbiome has increasingly been found to have links to many different diseases, and there is some evidence that changing the composition and diversity of the gut microbiome can have a beneficial effect on the immune system’s ability to regulate inflammation, a major part of managing UC.
MB310 is an oral capsule containing eight strains (types) of freeze-dried gut bacteria that have been shown to have potential health benefits. These strains occur naturally in healthy individuals and have been associated with clinical improvements in patients with UC following faecal microbiome transplantation (FMT). MB310 is designed to effectively deliver these bacteria to the intestines.
The purpose of this study is to investigate the safety, engraftment, and initial signs of clinical activity of MB310 in patients with active, mild-to-Moderate Ulcerative Colitis.
This is a first in human, phase 1b, randomized, placebo-controlled, double-blind clinical trial with patients receiving MB310 or matching placebo for 12 weeks. Participants will also receive vancomycin before starting MB310/matching placebo. Each participant will be in the study for up to 7 months, which includes a 3-month follow-up period.
Approximately 22 different sites across 5 countries will be taking part in the study, with an aim of recruiting a total of 30 participants, split 2:1 MB310 to matching placebo.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0403
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion