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NCT02330653 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
A Phase 1 study of Ulcerative Colitis and Crohn Disease, sponsored by Stacy A. Kahn.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02330653: Completed Phase 1 study of Ulcerative Colitis and Crohn Disease, sponsored by Stacy A. Kahn.
NCT02330653 is a Phase 1 study of Ulcerative Colitis and Crohn Disease that has completed, run by Stacy A. Kahn. The registered enrollment target is 15 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
NCT02330653, a Phase 1 study of Ulcerative Colitis and Crohn Disease, has completed, sponsored by Stacy A. Kahn.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) or active Crohn's colitis (CD) who have failed, are intolerant to, or have refused traditional first-line maintenance therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric UC or pediatric CD.
Primary Outcome
Number of participants with FMT-related adverse events grade 2 or above experienced in each arm.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Fecal Microbiota Transplant (FMT)
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-04-08 |
| Phase | Phase 1 |
What the finished NCT02330653 record still lists
NCT02330653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 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 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02330653 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02330653 about?
NCT02330653 is a clinical study titled "Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis". The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) or active Crohn's colitis (CD) ...
What is the current status of trial NCT02330653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2015-11. Estimated completion is 2019-04-08.
What conditions does trial NCT02330653 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT02330653?
The interventions under investigation include: Placebo (BIOLOGICAL), Fecal Microbiota Transplant (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02330653?
This trial is sponsored by Stacy A. Kahn, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02330653 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02330653's enrollment target sits among peer trials
15 119th of 122 higher than 4 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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