Ulcerative Colitis (UC)Phase 1/2ROOTNCT07913347
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
A Phase 1/2 study testing MGT-006, Vancomycin hydrochloride and Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole in people with Ulcerative Colitis (UC) and Ulcerative Colitis, Active Moderate, run by Metagen Therapeutics, Inc. at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
- What is being tested?
- MGT-006, Vancomycin hydrochloride and Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Jul 2026to 30 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients aged 18 to 75 years at the time of informed consent
- 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 cannot join
- 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 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).
- 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.
- 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
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- 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:
- HBsAg positive
- HCV antibody positive
- HIV-1/2 Ag/Ab screening-positive
- Patients currently receiving inpatient treatment for UC
- Patients suspected to have concurrent active intestinal obstruction or infectious enteritis
- 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)
- Patients with a history of hypersensitivity or allergy to excipients in MGT-006
- Patients with any of the following conditions that affect the lower gastrointestinal function
- 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)
- Patients who have used another investigational product within 12 weeks prior to informed consent
- Patients with serious allergies or contraindications to any drug used in this study
- (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)
- (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)
- (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
- Patients judged by the investigator (sub-investigator) to be inappropriate as subjects of this study
- (Phase 2a only) Participants who have previously received MGT-006
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Japan9 sites, 9 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431
- Recruiting
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
- Recruiting
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192
- Recruiting
The Jikei University Hospital
Minato-Ku, Tokyo, 105-0003
- Recruiting
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo, 108-8642
- Recruiting
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
- Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
United States3 sites, 3 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Not yet recruiting
GI PROS, Inc.
Naples, Florida, 34102
- Not yet recruiting
NYU Langone Health
New York, New York, 10016
About this study
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)
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.
Read the detailed description
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.
- Being tested
- MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- Keywords
- Ulcerative colitis, Fecal microbiota transplantation, Gut microbiota, FMT, Microbiome engraftment, Oral capsules
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGT-006Drug
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 hydrochlorideDrug
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/ MetronidazoleDrug
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 group | Role | What they receive |
|---|---|---|
| Phase 1b: MGT-006 Without Antibiotic Pretreatment | Experimental | 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. Receives: Drug: MGT-006 |
| Phase 1b: Vancomycin Pretreatment Followed by MGT-006 | Experimental | 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. Receives: Drug: MGT-006; Drug: Vancomycin hydrochloride |
| Phase 1b: AFM Pretreatment Followed by MGT-006 | Experimental | 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. Receives: Drug: MGT-006; Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole |
| Phase 2a: High-Dose MGT-006 | Experimental | The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. Receives: Drug: MGT-006; Drug: Vancomycin hydrochloride; Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole |
| Phase 2a: Medium-Dose MGT-006 | Experimental | The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. Receives: Drug: MGT-006; Drug: Vancomycin hydrochloride; Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole |
| Phase 2a: Low-Dose MGT-006 | Experimental | The dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. Receives: Drug: MGT-006; Drug: Vancomycin hydrochloride; Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Phase 1b: From first administration of study medication(MGT-006 or antibiotics) through four weeks after completion of MGT-006 treatment.
Secondary outcomes (2)
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.
Measured: 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
- 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
- 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.
- 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.
Measured: Week 8 after the first MGT-006 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start9 Jul 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study comprises two parts with parallel randomized treatment groups within each part. Phase 1b compares MGT-006 with No-pretreatment-antibiotics group, vancomycin group and AFM group (only for Japan). Phase 2a will explore MGT-006 doses and potentially alternative dosing regimens using the pretreatment approach selected in Phase 1b. Initiation and the final design of Phase 2a depend on review of Phase 1b safety, feasibility, and microbiome engraftment data and, as required, a protocol amendment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metagen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913347
- Sponsor's protocol ID
- MGT-006-UC-G1201
- Other IDs
- jRCT2071260030
- Acronym
- ROOT
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07913347
- Acronym / sponsor ID
- ROOT / MGT-006-UC-G1201
- Keywords
- Ulcerative colitis, Fecal microbiota transplantation, Gut microbiota, FMT, Microbiome engraftment, Oral capsules
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Metagen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- The study comprises two parts with parallel randomized treatment groups within each part. Phase 1b compares MGT-006 with No-pretreatment-antibiotics group, vancomycin group and AFM group (only for Japan). Phase 2a will explore MGT-006 doses and potentially alternative dosing regimens using the pretreatment approach selected in Phase 1b. Initiation and the final design of Phase 2a depend on review of Phase 1b safety, feasibility, and microbiome engraftment data and, as required, a protocol amendment.
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: MGT-006 Without Antibiotic Pretreatment | Experimental | Drug: MGT-006Participants 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. |
| Phase 1b: Vancomycin Pretreatment Followed by MGT-006 | Experimental | Drug: MGT-006, Drug: Vancomycin hydrochlorideParticipants 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. |
| Phase 1b: AFM Pretreatment Followed by MGT-006 | Experimental | Drug: MGT-006, Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ MetronidazoleSubjects 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. |
| Phase 2a: High-Dose MGT-006 | Experimental | Drug: MGT-006, Drug: Vancomycin hydrochloride, Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ MetronidazoleThe dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. |
| Phase 2a: Medium-Dose MGT-006 | Experimental | Drug: MGT-006, Drug: Vancomycin hydrochloride, Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ MetronidazoleThe dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. |
| Phase 2a: Low-Dose MGT-006 | Experimental | Drug: MGT-006, Drug: Vancomycin hydrochloride, Drug: Amoxicillin hydrate/ Fosfomycin calcium hydrate/ MetronidazoleThe dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Patients aged 18 to 75 years at the time of informed consent
- 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
Key exclusion criteria (24 listed)
- 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 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).
- 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.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGT-006MGT-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. | Drug | Phase 1b: AFM Pretreatment Followed by MGT-006, Phase 1b: MGT-006 Without Antibiotic Pretreatment, Phase 1b: Vancomycin Pretreatment Followed by MGT-006, Phase 2a: High-Dose MGT-006, Phase 2a: Low-Dose MGT-006, Phase 2a: Medium-Dose MGT-006 |
| Vancomycin hydrochlorideVancomycin 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. | Drug | Phase 1b: Vancomycin Pretreatment Followed by MGT-006, Phase 2a: High-Dose MGT-006, Phase 2a: Low-Dose MGT-006, Phase 2a: Medium-Dose MGT-006 |
| Amoxicillin hydrate/ Fosfomycin calcium hydrate/ MetronidazoleSubjects 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. | Drug | Phase 1b: AFM Pretreatment Followed by MGT-006, Phase 2a: High-Dose MGT-006, Phase 2a: Low-Dose MGT-006, Phase 2a: Medium-Dose MGT-006 |
Primary outcome
Safety and tolerability of MGT-006 (adverse events, adverse reactions)
Time frame: 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).
2 secondary outcomes
Engraftment of MGT-006-derived gut microbiota by 12 weeks after the start of MGT-006 administration
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
Time frame: Week 8 after the first MGT-006 administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MGT-006, Vancomycin hydrochloride and Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole in people with Ulcerative Colitis (UC) and Ulcerative Colitis, Active Moderate, run by Metagen Therapeutics, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metagen Therapeutics Clinical development devision (+81-235-33-9966, mgtx_cdu@metagentx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of MGT-006 (adverse events, adverse reactions) (time frame: Phase 1b: From first administration of study medication(MGT-006 or antibiotics) through four weeks after completion of MGT-006 treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.