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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
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
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
Blank placebo administered orally (in a capsule) once daily
Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12.
The MES ranges from 0 to 3, with higher scores indicating more severe disease.
Time frame: Week 12
To confirm the efficacy of MH002 to induce clinical remission at Week 12
Key secondary endpoint: Clinical remission is defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and an Rectal Bleeding (RB) subscore of 0, with endoscopic MES based on worst segment assessed by a blinded central reader, and 2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data
Time frame: Week 12
Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12
The RHI score ranges from 0 to 33, with higher scores indicating more severe disease activity.
Time frame: Week 12
(Median) Percent change from baseline in fecal calprotectin (FC) at Week 12
Time frame: Week 12
Change from baseline in UC-100 score at Week 12
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 score ranges from 1 to 100, with higher scores indicating more severe disease activity.
Time frame: Week 12
Change from baseline in PRO-2 score at Week 12
2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data on stool frequency and rectal bleed. The PRO-2 score ranges from 0 to 6, with higher scores indicating more severe disease.
Time frame: Week 12
To confirm the safety and tolerability of MH002 in the Induction Phase
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ARA Professionals
Miami, Florida, United States
RECRUITINGOrlando Gastroenterology, P.A.
Orlando, Florida, United States
RECRUITINGTropical Clinical Trials
Palmetto Bay, Florida, United States
RECRUITINGCross Creek Medical Clinic
Fayetteville, North Carolina, United States
RECRUITINGPeters Medical Research
High Point, North Carolina, United States
RECRUITINGSouthern Star Research Institute
San Antonio, Texas, United States
RECRUITINGJSC Georgian Clinics
Kutaisi, Georgia
RECRUITINGAmerican Hospital Network LLC
Tbilisi, Georgia
RECRUITINGK. Eristavi National Center of Experimental and Clinical Surgery JSC
Tbilisi, Georgia
RECRUITINGLTD Institute of Clinical Cardiology
Tbilisi, Georgia
RECRUITING...and 15 more locations
Incidence of Treatment-Emergent Adverse Events, Serious Adverse events Incidence of Treatment-emergent abnormalities in laboratory parameters and vital signs during 12 weeks treatment period.
Time frame: Up to Week 12