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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose MH002 | Experimental |
| |
| High-dose MH002 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Michel Muhlinghaus, DVM | Contact | +32 9 277 08 50 | clinicaltrials@mrmhealth.com | |
| Carmen Fleurinck, MD | Contact | +32 9 277 08 50 |
| Name | Affiliation | Role |
|---|---|---|
| Ludo Haazen, MD | MRM Health NV | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARA Professionals | Recruiting | Miami | Florida | 33155 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 |
|
| 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. | Week 12 |
| (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12 | 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. | 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. | Week 12 |
| To confirm the safety and tolerability of MH002 in the Induction Phase | 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. | Up to Week 12 |
| Orlando Gastroenterology, P.A. | Recruiting | Orlando | Florida | 32835 | United States |
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| Tropical Clinical Trials | Recruiting | Palmetto Bay | Florida | 33176 | United States |
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| Cross Creek Medical Clinic | Recruiting | Fayetteville | North Carolina | 28304 | United States |
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| Peters Medical Research | Recruiting | High Point | North Carolina | 27260 | United States |
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| Southern Star Research Institute | Recruiting | San Antonio | Texas | 78229 | United States |
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| JSC Georgian Clinics | Recruiting | Kutaisi | 4600 | Georgia |
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| American Hospital Network LLC | Recruiting | Tbilisi | 0102 | Georgia |
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| K. Eristavi National Center of Experimental and Clinical Surgery JSC | Recruiting | Tbilisi | 0159 | Georgia |
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| LTD Institute of Clinical Cardiology | Recruiting | Tbilisi | 0159 | Georgia |
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| Aversi Clinic LLC | Recruiting | Tbilisi | 0160 | Georgia |
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| LEPL The First University Clinic of Tbilisi State Medical University | Recruiting | Tbilisi | 0178 | Georgia |
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| LLC The First Medical Center | Recruiting | Tbilisi | 0180 | Georgia |
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| LTD Krol Medical Corporation | Recruiting | Tbilisi | 0180 | Georgia |
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| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC | Recruiting | Tbilisi | 0180 | Georgia |
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| PMSI "Timofei Mosneaga" Republican Clinical Hospital | Recruiting | Chisinau | MD2025 | Moldova |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |