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NCT05248191 · ClinicalTrials.gov registry record · Phase 1
FMT for Postop Crohn's Disease
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05248191: Completed Phase 1 study, sponsored by University of Minnesota.
NCT05248191 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05248191, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery. Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.
Primary Outcome
Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.
Interventions
- BIOLOGICAL Capsule fecal microbiota material (cap-FMT)
- BIOLOGICAL Colonoscopic fecal microbiota material (colo-FMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2024-05-16 |
| Phase | Phase 1 |
What the finished NCT05248191 record still lists
NCT05248191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Capsule fecal microbiota material (cap-FMT) is the first listed.
NCT05248191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05248191 about?
NCT05248191 is a clinical study titled "FMT for Postop Crohn's Disease". People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determin...
What is the current status of trial NCT05248191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2022-04-20. Estimated completion is 2024-05-16.
What interventions are being tested in trial NCT05248191?
The interventions under investigation include: Capsule fecal microbiota material (cap-FMT) (BIOLOGICAL), Colonoscopic fecal microbiota material (colo-FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05248191?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05248191's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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