Confirmatory Clinical Study in Active Ulcerative Colitis (NCT07296315)
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: ARA Professionals — Miami, Florida
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- ARA Professionals — Miami, Florida
- Orlando Gastroenterology, P.A. — Orlando, Florida
- Tropical Clinical Trials — Palmetto Bay, Florida
- Cross Creek Medical Clinic — Fayetteville, North Carolina
- Peters Medical Research — High Point, North Carolina
- Southern Star Research Institute — San Antonio, Texas
- JSC Georgian Clinics — Kutaisi,
- American Hospital Network LLC — Tbilisi,
- K. Eristavi National Center of Experimental and Clinical Surgery JSC — Tbilisi,
- LTD Institute of Clinical Cardiology — Tbilisi,
- Aversi Clinic LLC — Tbilisi,
- LEPL The First University Clinic of Tbilisi State Medical University — Tbilisi,
- LLC The First Medical Center — Tbilisi,
- LTD Krol Medical Corporation — Tbilisi,
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC — Tbilisi,
- PMSI "Timofei Mosneaga" Republican Clinical Hospital — Chisinau,
📞 Contact the Study Coordinator
Phone: (329) 277-0850
Email: clinicaltrials@mrmhealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colitis, Ulcerative
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis — Oakland, California
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis — Arcadia, California
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis — Litchfield Park, Arizona
- Determination of the Optimal Treatment Target in Ulcerative Colitis — Ypsilanti, Michigan
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis — Kelowna, British Columbia
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis — San Francisco, California
Explore by condition: All Colitis, Ulcerative clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.