RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing MGT-006 for Ulcerative Colitis (UC)

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.

Official registry: https://clinicaltrials.gov/study/NCT07913347 · Metagen Therapeutics, Inc. · enrollment listed as 54

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MGT-006, Vancomycin hydrochloride, or Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole. The registry lists allocation as randomized. Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine.

They plan to enroll about 54 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole

Primary outcome (registry wording): Safety and tolerability of MGT-006 (adverse events, adverse reactions)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Patients who have been diagnosed with UC through endoscopic and histological examination for at least 12 weeks at the time of final registration
Patients with a modified Mayo Score of 4 to 7 at the time of final registration

Who the registry excludes

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
Patients with suspected or confirmed colorectal cancer or high-grade dysplasia
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
Patients with any of the following will be excluded:
HCV antibody positive

Public study contact (from the registry)

Metagen Therapeutics Clinical development devision

+81-235-33-9966

mgtx_cdu@metagentx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

12 listed

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)

+ 9 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07913347 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07913347?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07913347?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary