Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Safety and tolerability of MGT-006 (adverse events, adverse reactions) — Phase 1b: From first administration of study medication(MGT-006 or antibiotics) through four weeks after completion of MGT-006 treatment.
The number and percentage of subjects experiencing the AEs will be calculated for each group and overall. If a subject experiences multiple AEs, the subject will be counted only once per category. Similar summaries will be provided for adverse events related to the study drugs or procedures. These related adverse events will be summarized together in a single table by the source of relationship (i.e., MGT-006, pretreatment antibiotics, and study procedures).
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| GI PROS, Inc. | Naples | Florida | Not Yet Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Not Yet Recruiting |
| NYU Langone Health | New York | New York | Not Yet Recruiting |
| Fukuoka University Hospital | Fukuoka | Fukuoka | Recruiting |
| Sapporo Medical University Hospital | Sapporo | Hokkaido | Recruiting |
| Kawasaki Medical School Hospital | Kurashiki | Okayama-ken | Recruiting |
| Kansai Medical University Hospital | Hirakata | Osaka | Recruiting |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | Recruiting |
| Juntendo University Hospital | Bunkyō-Ku | Tokyo | Recruiting |
| The Jikei University Hospital | Minato-Ku | Tokyo | Recruiting |
| Kitasato University Kitasato Institute Hospital | Minato-Ku | Tokyo | Recruiting |
| Kyorin University Hospital | Mitaka | Tokyo | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07913347 on ClinicalTrials.gov ↗ ← All trials in the USA