Clinical Trial

Confirmatory Clinical Study in Active Ulcerative Colitis

Study acronym: StarFish-UC
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
Protocol Amendment History 3 changes
notable Trial sites expanded: 10 -> 14 locations 2026-06-26
notable Trial sites expanded: 7 -> 10 locations 2026-06-16
notable Trial sites expanded: 1 -> 5 locations 2026-05-15
Trial Details
NCT Number NCT07296315
Lead Sponsor MRM Health NV
Conditions Colitis, Ulcerative
Enrollment 204 participants
Start Date 2026-04-03
Primary Completion 2027-09 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-09