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NCT02516384 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02516384: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT02516384 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02516384, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Inflammatory bowel disease is a condition caused by gastrointestinal immune system dysregulation and affected by both genetic and environmental factors. Differences in intestinal bacteria exist between IBD patients and healthy controls, but the role of intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy donor to a patient with altered microbial diversity with the intent of restoring a normal bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively examine the safety of FMT in the management of ulcerative colitis (UC).
Primary Outcome
Patient information regarding adverse events and safety of FMT for UC will be collected throughout the study period, including day 0, weeks 1, 2, 4, 6, 12 24, and then every 6 months until 36 months post-FMT. Throughout the study period, patients will be assessed for safety with questions regarding general well-being (such as "how have you been feeling?"), as well as specific questions to evaluate for occurrence of adverse events. Patients will also be questioned regarding stool form and frequen
Interventions
- BIOLOGICAL Fecal Microbiota Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 1 |
What the finished NCT02516384 record still lists
NCT02516384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT02516384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02516384 about?
NCT02516384 is a clinical study titled "Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)". Inflammatory bowel disease is a condition caused by gastrointestinal immune system dysregulation and affected by both genetic and environmental factors. Differences in intestinal bacteria exist between IBD patients and healthy controls, but the role of intestinal bacteria in the development and trea...
What is the current status of trial NCT02516384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-10-01. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02516384?
The interventions under investigation include: Fecal Microbiota Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02516384?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02516384's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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