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NCT06631586 · ClinicalTrials.gov registry record · Phase 2
Standardized Microbiota Transplant Therapy in Crohn's Disease
A Phase 2 study of Crohn Disease, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06631586: Recruiting Phase 2 study of Crohn Disease, sponsored by University of Minnesota.
NCT06631586 is a Phase 2 study of Crohn Disease that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 120 participants, below the 204-participant average among 71 other Crohn Disease trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06631586, a Phase 2 study of Crohn Disease, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.
Primary Outcome
measured in intestinal ileal biopsies
Conditions Studied
Interventions
- BIOLOGICAL MTP-101C
- BIOLOGICAL MTP-101S
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2029-06-15 |
| Phase | Phase 2 |
What NCT06631586 shows while recruiting
NCT06631586 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 71 other Crohn Disease trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which MTP-101C is the first listed.
NCT06631586 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06631586 about?
NCT06631586 is a clinical study titled "Standardized Microbiota Transplant Therapy in Crohn's Disease". Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (...
What is the current status of trial NCT06631586?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-01-15. Estimated completion is 2029-06-15.
What conditions does trial NCT06631586 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT06631586?
The interventions under investigation include: MTP-101C (BIOLOGICAL), MTP-101S (BIOLOGICAL).
Who is sponsoring clinical trial NCT06631586?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631586 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06631586's enrollment target sits among peer trials
120 32nd of 71 higher than 40 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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