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Recruiting Phase 1/2

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

NCT07913347 · tracked via the Priya Life Science USA tracker
Sponsor
Metagen Therapeutics, Inc
Phase
Phase 1/2
Started
2026-07-09
Last updated
2026-11-03

Condition(s) studied

Ulcerative Colitis (UC)Ulcerative Colitis, Active Moderate

Investigational drug(s) / intervention(s)

MGT-006Vancomycin hydrochloride →Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients who understand the contents of this clinical study, sign a written informed consent form, and possess the willingness and capability to participate in all medical examinations, evaluations, and follow-ups related to the study. 2. Patients aged 18 to 75 years at the time of informed consent 3. Patients who have been diagnosed with UC through endoscopic and histological examination for at least 12 weeks at the time of final registration 4. Patients with a modified Mayo Score of 4 to 7 at the time of final registration Exclusion Criteria: 1. Patients with any of the following medical history or complications, or those undergoing concomitant therapy, which the investigator (sub-investigator) to be serious or clinically significant 2. Patients with past or concurrent malignant tumors; however, cured basal cell carcinoma of the skin is allowed for registration. In addition, breast cancer in remission for \>= 10 years without recurrence is allowed for registration, and other malignant tumors in remission for \>= 5 years are allowed for registration if no therapeutic intervention is required and they are in stable condition, as determined by the investigator (sub-investigator). 3. Patients with pancolitis of \> 8 years' duration or left-sided colitis of \> 8 years' duration who have not undergone a surveillance flexible sigmoidoscopy or total colonoscopy (performed according to local standard of care) within 12 months prior to screening to rule out colorectal dysplasia/cancer. 4. Patients with suspected or confirmed colorectal cancer or high-grade dysplasia. 5. Patients with any of the following abnormal values in clinical laboratory tests performed within 4 weeks prior to final registration in this clinical study: * Patients with a serum creatinine level of \>= 2.0 mg/dL or a BUN level of \>= 25 mg/dL * Patients with a total bilirubin level of \>= 3.0 mg/dL, or an AST (GOT) or ALT (GPT) level of \>= 100 IU/L 6. Patients with any of the following will be excluded: * HBsAg positive * HCV antibody positive * HIV-1/2 Ag/Ab screening-positive 7. Patients currently receiving inpatient treatment for UC 8. Patients suspected to have concurrent active intestinal obstruction or infectious enteritis 9. Patients with Clostridioides difficile infection (C. difficile infection) (patients in whom the presence or absence of infection is confirmed by NAAT and the result is positive) 10. Patients with a history of hypersensitivity or allergy to excipients in MGT-006 11. Patients with any of the following conditions that affect the lower gastrointestinal function 12. Patients who have failed or been intolerant to \>= 3 advanced-therapy mechanistic classes for ulcerative colitis (e.g., anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitor, S1P modulator) 13. Patients who have used another investigational product within 12 weeks prior to informed consent 14. Patients with serious allergies or contraindications to any drug used in this study 15. (Females only) Patients in whom the result of a pregnancy test performed within 4 weeks prior to final registration is positive (if a urine hCG test is positive, a negative serum pregnancy test result should be confirmed) 16. (Females only) Patients who are pregnant or breastfeeding, or females of childbearing potential unable to use appropriate contraceptive methods from the date of informed consent to 12 weeks post-treatment. (e.g., intrauterine device, diaphragm, partner's use of condom) 17. (Males only) Patients who are males of reproductive potential (including partners of childbearing potential) unable to use at least one effective contraceptive method from the time of informed consent until 12 weeks after the end of investigational drug administration 18. Patients judged by the investigator (sub-investigator) to be inappropriate as subjects of this study 19. (Phase 2a only) Participants who have previously received MGT-006

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)

FacilityCityRegionStatus
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
Official registry record

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