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NCT02058524 · ClinicalTrials.gov registry record · Phase 1
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
A Phase 1 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02058524: Clinical Trial Phase 1 study, sponsored by University of Chicago.
NCT02058524 is a Phase 1 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02058524, a Phase 1 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
Primary Outcome
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
Interventions
- BIOLOGICAL fecal microbiota transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
Why NCT02058524 stopped before completion
NCT02058524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which fecal microbiota transplantation is the first listed.
NCT02058524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02058524 about?
NCT02058524 is a clinical study titled "A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis". The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered c...
What is the current status of trial NCT02058524?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2013-06. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02058524?
The interventions under investigation include: fecal microbiota transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02058524?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02058524's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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