Trial · NCT07913347
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
NCT07913347, Phase 1, Phase 2, Recruiting, Metagen Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study). Trials, record NCT07913347. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
- NCT number
- NCT07913347
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, estimated
- Lead sponsor
- Metagen Therapeutics, Inc.
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
- Interventions
- MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Secondary | Engraftment of MGT-006-derived gut microbiota by 12 weeks after the start of MGT-006 administration | Up to 12 weeks after the first 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. |
| Secondary | 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 | Week 8 after the first MGT-006 administration. | 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. |
| Other | 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 | Baseline to Week 8 after the first MGT-006 administration. | \<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 |
| Other | Changes in Partial Mayo Score and each subscore from baseline to 12 weeks after the start of MGT-006 administration | Baseline to Week 12 after the first 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. |
| Other | Changes in gut microbiota from baseline to 12 weeks after the start of MGT-006 administration | Baseline to Week 12 after the first 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. |
| Other | Dietary surveys in subjects at baseline and at 12 weeks after the start of MGT-006 administration | Baseline and Week 12 after the first MGT-006 administration. | A dietary survey of subjects will be conducted by questionnaire according to "Appendix 4 Survey Items for Dietary Survey." |
| Other | Patient acceptability assessment of MGT-006 as a patient-reported outcome (PRO) at 12 weeks after the start of MGT-006 administration | Week 12 after the first 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)." |
| Other | Medication adherence status for MGT-006 and pretreatment antibiotics (for subjects assigned to pretreatment antibiotics). | Baseline through Week 12 after the first MGT-006 administration. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913347
GET https://conductscience.org/api/trials/v1/NCT07913347/registered