A Phase 1/2 interventional study of MGT-006 and Vancomycin hydrochloride in Ulcerative Colitis (UC) and Ulcerative Colitis, Active Moderate, sponsored by Metagen Therapeutics, Inc.. Recruiting at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Metagen Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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.
The study is a multicenter, randomized, exploratory Phase 1b/2a study planned at approximately 30 sites in Japan and the United States. The study is intended to evaluate the safety and tolerability of repeated oral administration of MGT-006, select an appropriate pretreatment approach, and explore dose and regimen options for further development.
In Phase 1b, participants will be randomized in three cohots, MGT-006 without pretreatment antibiotics or to oral vancomycin or AFM (Amoxicillin/Fosfomycin/Metronidazole) pretreatment followed by MGT-006. Randomization will be stratified by country. The planned sample size is approximately 18 participants, with additional enrollment permitted as needed to obtain at least six evaluable participants per group meeting the protocol-defined adherence criteria.
Progression to Phase 2a is conditional on the safety and microbiome engraftment review specified in the protocol. The sponsor will make the transition decision taking into account the independent Data Safety Monitoring Board's recommendations, as applicable. Approximately 36 participants across three MGT-006 dose groups are provisionally planned for Phase 2a. The number of groups, doses, dosing regimens, sample size, and treatment duration may be modified based on Phase 1b findings and will be specified in an amended protocol before initiation of Phase 2a.
Treatment administration is open-label. Endoscopic efficacy assessments will be performed centrally without knowledge of treatment allocation. Safety data will be reviewed by an independent Data Safety Monitoring Board. Analyses will be descriptive and exploratory; the study is not designed for confirmatory hypothesis testing or to ensure statistical power for between-group comparisons.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 54 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →This is the only study on the registry with Metagen Therapeutics, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 any of the following will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: MGT-006
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.
Drug: MGT-006 · Drug: Vancomycin hydrochloride
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.
Drug: MGT-006 · Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
Drug: MGT-006 · Drug: Vancomycin hydrochloride · Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
Drug: MGT-006 · Drug: Vancomycin hydrochloride · Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress.
Drug: MGT-006 · Drug: Vancomycin hydrochloride · Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
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 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.
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.
Safety and tolerability of MGT-006 (adverse events, adverse reactions)
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).
Time frame: Phase 1b: From first administration of study medication(MGT-006 or antibiotics) through four weeks after completion of MGT-006 treatment.
Engraftment of MGT-006-derived gut microbiota by 12 weeks after the start of MGT-006 administration
Engraftment is defined at the strain (clonal) level. Specifically, a strain detected in the MGT-006 product lot is considered engrafted when it is detected in the participant after dosing. Detection sensitivity depends on the genetic distance between the product-derived strain and a baseline endogenous strain of the same species retained by the participant, as measured by the number of SNVs in species-specific marker genes.
Time frame: Up to 12 weeks after the first MGT-006 administration.
The following efficacy endpoints at 8 weeks after the start of MGT-006 administration based on central imaging assessment: (1) Clinical remission rate (2) Clinical response rate (3) Endoscopic improvement rate
1. Clinical remission rate is the percentage of subjects who achieved all of the following scores based on the MMS: * Stool frequency subscore of ≤1 and no greater than baseline * Rectal bleeding subscore of 0 points * Endoscopic subscore of ≤1 point 2. Clinical response rate is the percentage of subjects who achieved all of the following scores based on the MMS: * MMS decreased by ≥2 points and ≥30% from baseline * Rectal bleeding subscore decreased ≥1 point from baseline or became ≤1 point. 3. Endoscopic improvement rate is the percentage of subjects whose endoscopic subscore is ≤1 point. For efficacy parameters in this clinical study, the MMS will be used.
Time frame: Week 8 after the first MGT-006 administration.
Changes in MMS score, endoscopic subscore, and UCEIS from baseline to 8 weeks after the start of MGT-006 administration based on central imaging assessment
\<Endoscopic Subscore\> At the time of confirmation of subject enrollment criteria (Visit 1), the investigator (sub-investigator) will evaluate the endoscopic subscore. The endoscopic subscore as an efficacy endpoint (Visit 1, Visit 7) will be evaluated by the Central Evaluation Committee. \<UCEIS\> The Central Imaging Evaluation Committee will evaluate three items: vascular pattern, bleeding, and erosions and ulcers. The following will be used for evaluation in this study: * UCEIS endoscopic remission rate: Score of 0 at 8 weeks after the start of MGT-006 administration * UCEIS endoscopic improvement rate: Score decreased by 2 or more from baseline at 8 weeks after the start of MGT-006 administration
Time frame: Baseline to Week 8 after the first MGT-006 administration.
Changes in Partial Mayo Score and each subscore from baseline to 12 weeks after the start of MGT-006 administration
Partial Mayo score: Total score of 3 subscores excluding endoscopic subscore among the Mayo scores (0 to 12) Summary statistics will be calculated for the measured values and changes from baseline in the Partial Mayo Score at each evaluation time point.
Time frame: Baseline to Week 12 after the first MGT-006 administration.
Changes in gut microbiota from baseline to 12 weeks after the start of MGT-006 administration
Change from baseline is calculated per participant as the value at each post-dose timepoint minus the value at baseline, for the following indices: species richness, Shannon index, Bray-Curtis dissimilarity to donor, and Jaccard similarity to donor.
Time frame: Baseline to Week 12 after the first MGT-006 administration.
Dietary surveys in subjects at baseline and at 12 weeks after the start of MGT-006 administration
A dietary survey of subjects will be conducted by questionnaire according to "Appendix 4 Survey Items for Dietary Survey."
Time frame: Baseline and Week 12 after the first MGT-006 administration.
Patient acceptability assessment of MGT-006 as a patient-reported outcome (PRO) at 12 weeks after the start of MGT-006 administration
A patient acceptability assessment of MGT-006 will be conducted by questionnaire according to "Appendix 5 Patient Acceptability Assessment of MGT-006 as a Patient-Reported Outcome (PRO)."
Time frame: Week 12 after the first MGT-006 administration.
Medication adherence status for MGT-006 and pretreatment antibiotics (for subjects assigned to pretreatment antibiotics).
Subjects will record administration of study medications in a medication diary, including: * Pretreatment antibiotics (if assigned, e.g., vancomycin) * Investigational product (MGT-006) The diary will capture, at minimum, the date of administration and any missed doses. For the FAS, PPS and SAS, the medication adherence rate for the entire pretreatment antibiotics administration period will be calculated. For the AFM group, the adherence rate will be calculated and summarized for each drug (amoxicillin, fosfomycin, and metronidazole) separately.
Time frame: Baseline through Week 12 after the first MGT-006 administration.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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