MGT-006 for Ulcerative Colitis
(ROOT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with moderately active ulcerative colitis. Participants should not have other major health issues that could interfere with the study, and must be able to take oral medications as directed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- MGT-006
- Vancomycin hydrochloride
Trial Overview
The study tests MGT-006, a capsule containing healthy gut bacteria from donors, in people with ulcerative colitis. Some participants will get antibiotics before taking MGT-006 to see if this helps the treatment work better. The trial looks at safety, best dose, and how well the new bacteria settle in.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
Participants receive oral vancomycin hydrochloride at a total daily dose of 500 mg (as vancomycin), divided into four daily administrations, for five days. MGT-006 is then administered orally at four capsules per dose, three times daily before meals, for 56 days, followed by four weeks of observation. MGT-006 starts within two days after completion of vancomycin pretreatment.
Participants receive no antibiotic pretreatment. MGT-006 is administered orally at four capsules per dose, three times daily before meals, for 56 days. Participants are observed for four weeks after completion of MGT-006 treatment.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Metagen Therapeutics, Inc.
Lead Sponsor
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