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NCT03194529 · ClinicalTrials.gov registry record · Phase 1
FMT in Pediatric Crohn's Disease
A Phase 1 study of Crohn Disease and Pediatric Crohn's Disease, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03194529 is a Phase 1 study of Crohn Disease and Pediatric Crohn's Disease that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 9 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03194529, a Phase 1 study of Crohn Disease and Pediatric Crohn's Disease, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in children with Crohn's disease who are in remission. Safety will be the primary endpoint and Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other secondary endpoints including changes in gut microbial diversity will also be studied. All children will receive the equivalent of 50g of stools from a healthy donor into the jejunum through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits within 24 weeks including phone call follow up on Day 7 after FMT.
Conditions Studied
Interventions
- BIOLOGICAL FMT
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03194529
The ClinicalTrials.gov registry entry for NCT03194529 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (96% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention - of which FMT is the first listed.
NCT03194529 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03194529 about?
NCT03194529 is a clinical study titled "FMT in Pediatric Crohn's Disease". The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in children with Crohn's disease who are in remission. Safety will be the primary endpoint and Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other secondary endpoints includi...
What is the current status of trial NCT03194529?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2017-10-09. Estimated completion is 2019-07-31.
What conditions does trial NCT03194529 study?
This clinical trial studies the following conditions: Crohn Disease, Pediatric Crohn's Disease.
What interventions are being tested in trial NCT03194529?
The interventions under investigation include: FMT (BIOLOGICAL).
Who is sponsoring clinical trial NCT03194529?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03194529 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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