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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02330653
The ClinicalTrials.gov registry entry for NCT02330653 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The listed sponsor is Stacy A. Kahn, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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