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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 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02516384
The ClinicalTrials.gov registry entry for NCT02516384 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT02516384 reports 0 study locations.
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.
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