Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Public ClinicalTrials.gov record NCT07913347. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07913347
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 54 participants
Conditions and interventions
Interventions
- MGT-006 Drug
- Vancomycin hydrochloride Drug
- Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 9, 2026 (Actual)
- Primary completion
- Mar 31, 2028 (Estimated)
- Completion
- Sep 30, 2028 (Estimated)
- Last update posted
- Nov 3, 2026
2026 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GI PROS, Inc. | Naples | Florida | 34102 | Not yet recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Not yet recruiting |
| NYU Langone Health | New York | New York | 10016 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07913347, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2026 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07913347 live on ClinicalTrials.gov.