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RECRUITING
NCT07913347
PHASE1/PHASE2

Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)

Sponsor: Metagen Therapeutics, Inc.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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