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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 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05248191
The ClinicalTrials.gov registry entry for NCT05248191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Capsule fecal microbiota material (cap-FMT) is the first listed.
NCT05248191 reports 0 study locations.
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.
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