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Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Sponsor: Metagen Therapeutics, Inc.
Summary
Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine. MGT-006 is an investigational oral capsule containing viable gut microbiota from screened human donors. This study will evaluate the safety and tolerability of MGT-006 in adults with moderately active ulcerative colitis. It will also examine whether gut microbiota from MGT-006 engraft in participants' intestines and explore changes in ulcerative colitis symptoms and inflammation. The study has two parts. In Phase 1b, participants will be randomly assigned to receive MGT-006 either without antibiotic pretreatment or after five days of oral vancomycin or AFM (Amoxicillin/Fosfomycin/Metronidazole) pretreatment. MGT-006 will be taken for eight weeks, followed by four weeks of observation. Phase 2a is planned to explore different doses and potentially different dosing regimens of MGT-006, using the pretreatment approach selected from Phase 1b. The final Phase 2a design will depend on the Phase 1b findings and will be specified in an amended protocol before Phase 2a begins.
Official title: Phase 1b/2a Study of MGT-006 in Patients With Ulcerative Colitis: A Dose and Preparation Regimen Selection Trial to Assess Safety and Microbiome Engraftment (ROOT Study)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2026-07-09
Completion Date
2028-09-30
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
MGT-006
MGT-006 is an investigational enteric-coated oral capsule filled with lyophilized human fecal material containing viable gut microbiota. In Phase 1b, four capsules are taken three times daily before meals for 56 days (12 capsules per day). Dose reduction, interruption, discontinuation, and re-escalation may occur according to protocol-defined safety rules. Phase 2a doses, dosing frequency, and treatment duration will be determined based on Phase 1b findings and specified in an amended protocol.
Vancomycin hydrochloride
Vancomycin hydrochloride is administered orally as pretreatment at a total daily dose of 500 mg (as vancomycin), divided into four daily administrations, for five days before MGT-006. In Phase 1b, it is administered only to participants randomized to the vancomycin pretreatment arm. Its use in Phase 2a depends on the pretreatment approach selected from Phase 1b.
Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
Subjects allocated to the AFM group will receive pretreatment antibiotics for 5 days after final registration. Amoxicillin hydrate 1500 mg/day (as amoxicillin), fosfomycin calcium hydrate 3000 mg/day (as fosfomycin), and metronidazole 750 mg/day will be orally administered three times a day for 5 days. Its use in Phase 2a depends on the pretreatment approach selected from Phase 1b.
Locations (12)
GI PROS, Inc.
Naples, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan