Confirmatory Clinical Study in Active Ulcerative Colitis

Part of paid clinical trials in Miami, Florida.

Sponsor
MRM Health NV
Study ID
NCT07296315
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-dose MH002 — DRUG
    Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 1 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
  • High-dose MH002 — DRUG
    Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 4 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
  • Placebo — DRUG
    Blank placebo administered orally (in a capsule) once daily

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose MH002
  • Experimental: High-dose MH002
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12. [ Time Frame: Week 12 ]

Central Contacts

  • Jean-Michel Muhlinghaus, DVM
    +32 9 277 08 50
    [email protected]
  • Carmen Fleurinck, MD
    +32 9 277 08 50

Locations (5)

FacilityCityStateZIPSite coordinators
ARA ProfessionalsMiamiFlorida33155
Sergio Rodriguez
Tropical Clinical TrialsPalmetto BayFlorida33176
Michael Feldman
Cross Creek Medical ClinicFayettevilleNorth Carolina28304
Nitinchandra D. Desai
Peters Medical ResearchHigh PointNorth Carolina27260
Roy Peters
Southern Star Research InstituteSan AntonioTexas78229
Jeff Bullock

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ARA Professionals· Miami, FLTropical Clinical Trials· Palmetto Bay, FLCross Creek Medical Clinic· Fayetteville, NCPeters Medical Research· High Point, NCSouthern Star Research Institute· San Antonio, TX

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