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NCT03948919 · ClinicalTrials.gov registry record · Phase 1
Fecal Transplant for Ulcerative Colitis
A Phase 1 study of Ulcerative Colitis, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03948919: Completed Phase 1 study of Ulcerative Colitis, sponsored by University of Minnesota.
NCT03948919 is a Phase 1 study of Ulcerative Colitis that has completed, run by University of Minnesota. The registered enrollment target is 26 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03948919, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at baseline and after FMT. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. We aim to determine if we can alter the microbiota in UC towards a healthy, more diverse microbiota resembling the donor using capsule FMT material.
Primary Outcome
Engraftment measured by SourceTracker at baseline to week 12 between FMT arm and placebo arm.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fecal microbiota
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2024-01-04 |
| Phase | Phase 1 |
What the finished NCT03948919 record still lists
NCT03948919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03948919 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03948919 about?
NCT03948919 is a clinical study titled "Fecal Transplant for Ulcerative Colitis". The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at...
What is the current status of trial NCT03948919?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-07-31. Estimated completion is 2024-01-04.
What conditions does trial NCT03948919 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT03948919?
The interventions under investigation include: Placebo (DRUG), Fecal microbiota (DRUG).
Who is sponsoring clinical trial NCT03948919?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03948919 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
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Where NCT03948919's enrollment target sits among peer trials
26 107th of 122 higher than 15 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
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