Confirmatory Clinical Study in Active Ulcerative Colitis
Start Date
4/3/2026
Completion Date
5/1/2028
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 Criteria
Age Range: 16 years to No maximum
Interventions
Low-dose MH002
High-dose MH002
Placebo
Conditions
Locations
ARA Professionals
Miami, Florida 33155
United States
Orlando Gastroenterology, P.A.
Orlando, Florida 32835
United States
Tropical Clinical Trials
Palmetto Bay, Florida 33176
United States
Cross Creek Medical Clinic
Fayetteville, North Carolina 28304
United States
Peters Medical Research
High Point, North Carolina 27260
United States
Southern Star Research Institute
San Antonio, Texas 78229
United States
Military Hospital Brno, Internal Department
Brno, 61500
Czechia
Thomayer University Hospital, Clinic of Internal Medicine
Prague, 14000
Czechia
JSC Georgian Clinics
Kutaisi, 4600
Georgia
American Hospital Network LLC
Tbilisi, 0102
Georgia
K. Eristavi National Center of Experimental and Clinical Surgery JSC
Tbilisi, 0159
Georgia
LTD Institute of Clinical Cardiology
Tbilisi, 0159
Georgia
Aversi Clinic LLC
Tbilisi, 0160
Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0178
Georgia
LLC The First Medical Center
Tbilisi, 0180
Georgia
LTD Krol Medical Corporation
Tbilisi, 0180
Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0180
Georgia
Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau, 2005
Moldova
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, MD-2025
Moldova
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, MD2025
Moldova
"Sfanta Treime" Municipal Clinical Hospital
Chisinau, MD2068
Moldova
Vita Longa Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748
Poland
Oslomed Medical Center
Krakow, 31-228
Poland
Endoskopia Sp. z o.o. (LLC)
Sopot, 81-756
Poland
Clinical Research Center Early-Phase Research Facility
Wroclaw, 51-162
Poland
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000
Serbia
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
Belgrade, 11000
Serbia
General Hospital Leskovac
Leskovac, 16000
Serbia
General Hospital 'Dr Radivoj Simonovic' Sombor
Sombor, 25000
Serbia
Health Center Užice
Užice, 31000
Serbia
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001
Ukraine
Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, 76008
Ukraine
LLC "Treatment and Diagnostic Center "Adonis Plus"
Kyiv, 02002
Ukraine
Medical Center "Artes Medicum" LLC
Kyiv, 02002
Ukraine
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
Kyiv, 02091
Ukraine
Limited Liability Company "Medical Centre "Consilium Medical"
Kyiv, 04050
Ukraine
Limited Liability Company "Center of Family Medicine Plus"
Kyiv, 04210
Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010
Ukraine
Municipal Non-Commercial Enterprise "Uzhhorod City Multidisciplinary Clinical Hospital" of Uzhhorod City Council
Uzhhorod, 88009
Ukraine
Limited Liability Company "Treatment and Diagnostic Center "Gastroclinic"
Vinnytsia, 21021
Ukraine