Confirmatory Clinical Study in Active Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Low-dose MH002: 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: 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: Blank placebo administered orally (in a capsule) once daily
Study 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.
Eligibility
Primary outcome measure(s)
- Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12. — Week 12
The MES ranges from 0 to 3, with higher scores indicating more severe disease.
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| ARA Professionals | Miami | Florida | Recruiting |
| Orlando Gastroenterology, P.A. | Orlando | Florida | Recruiting |
| Tropical Clinical Trials | Palmetto Bay | Florida | Recruiting |
| Cross Creek Medical Clinic | Fayetteville | North Carolina | Recruiting |
| Peters Medical Research | High Point | North Carolina | Recruiting |
| Southern Star Research Institute | San Antonio | Texas | Recruiting |
| Military Hospital Brno, Internal Department | Brno | Czechia | Recruiting |
| Thomayer University Hospital, Clinic of Internal Medicine | Prague | Czechia | Recruiting |
| JSC Georgian Clinics | Kutaisi | Georgia | Recruiting |
| American Hospital Network LLC | Tbilisi | Georgia | Recruiting |
| K. Eristavi National Center of Experimental and Clinical Surgery JSC | Tbilisi | Georgia | Recruiting |
| LTD Institute of Clinical Cardiology | Tbilisi | Georgia | Recruiting |
| Aversi Clinic LLC | Tbilisi | Georgia | Recruiting |
| LEPL The First University Clinic of Tbilisi State Medical University | Tbilisi | Georgia | Recruiting |
| LLC The First Medical Center | Tbilisi | Georgia | Recruiting |
| LTD Krol Medical Corporation | Tbilisi | Georgia | Recruiting |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC | Tbilisi | Georgia | Recruiting |
| Sf. Arhanghel Mihail" Municipal Clinical Hospital | Chisinau | Moldova | Recruiting |
| PMSI "Timofei Mosneaga" Republican Clinical Hospital | Chisinau | Moldova | Recruiting |
| PMSI "Timofei Mosneaga" Republican Clinical Hospital | Chisinau | Moldova | Recruiting |
| "Sfanta Treime" Municipal Clinical Hospital | Chisinau | Moldova | Recruiting |
| Vita Longa Non-Public Healthcare Facility, Limited Liability Company | Katowice | Poland | Recruiting |
| Oslomed Medical Center | Krakow | Poland | Recruiting |
| Endoskopia Sp. z o.o. (LLC) | Sopot | Poland | Recruiting |
| Clinical Research Center Early-Phase Research Facility | Wroclaw | Poland | Recruiting |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | Serbia | Recruiting |
| Clinical Hospital Center Dr. Dragisa Misovic-Dedinje | Belgrade | Serbia | Recruiting |
| General Hospital Leskovac | Leskovac | Serbia | Recruiting |
| General Hospital 'Dr Radivoj Simonovic' Sombor | Sombor | Serbia | Recruiting |
| Health Center Užice | Užice | Serbia | Recruiting |
| Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" | Chernivtsi | Ukraine | Recruiting |
| Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council" | Ivano-Frankivsk | Ukraine | Recruiting |
| LLC "Treatment and Diagnostic Center "Adonis Plus" | Kyiv | Ukraine | Recruiting |
| Medical Center "Artes Medicum" LLC | Kyiv | Ukraine | Recruiting |
| Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research" | Kyiv | Ukraine | Recruiting |
| Limited Liability Company "Medical Centre "Consilium Medical" | Kyiv | Ukraine | Recruiting |
| Limited Liability Company "Center of Family Medicine Plus" | Kyiv | Ukraine | Recruiting |
| Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital" | Lviv | Ukraine | Recruiting |
| Municipal Non-Commercial Enterprise "Uzhhorod City Multidisciplinary Clinical Hospital" of Uzhhorod City Council | Uzhhorod | Ukraine | Recruiting |
| Limited Liability Company "Treatment and Diagnostic Center "Gastroclinic" | Vinnytsia | Ukraine | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07296315 on ClinicalTrials.gov ↗ ← All trials in Czechia