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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06631586
The ClinicalTrials.gov registry entry for NCT06631586 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 71 other Crohn Disease trials with a reported enrollment target (41% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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