Confirmatory Clinical Study in Active Ulcerative Colitis

Study acronym: StarFish-UC
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Minor Trial sites expanded: 25 → 40 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 3 of 6 entries
  2. Minor Trial sites expanded: 16 → 25 locationsv10
  3. Minor Study sites: 15 to 16v9
  4. Minor Study sites: 14 to 15v8
  5. Minor Trial sites expanded: 10 → 14 locationsv7
  6. Minor Trial sites expanded: 7 → 10 locationsv6
  7. Minor Study sites: 5 to 7v5
  8. Minor Re-verified, no change to tracked fieldsv4
  9. Minor Trial sites expanded: 1 → 5 locations
    • Secondary endpoints: details revised at 4 of 6 entries
    • Primary endpoint revised
    v3
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2026 to Apr 3, 2026
    • Site details revised
    v2
  11. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07296315
Lead Sponsor MRM Health NV
Conditions
(from sponsor)
Colitis, Ulcerative
Related terms Colitis, Ulcerative
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov