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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: Completed Phase 1 study of Crohn Disease and Pediatric Crohn's Disease, sponsored by Children's Hospital Los Angeles.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Safety will be closely monitored (during defined telephone calls and study visits) and adverse events will be documented, including mucosal inflammation episodes and standard of care laboratory test abnormalities.

Conditions Studied

Crohn Disease Pediatric Crohn's Disease

Interventions

  • BIOLOGICAL FMT

Study Locations (1)

California

  • Children's Hospital Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2017-10-09
Est. Completion 2019-07-31
Phase Phase 1
Children's Hospital Los Angeles

119 total trials

What the finished NCT03194529 record still lists

NCT03194529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Crohn Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03194529's enrollment target sits among peer trials

9 71st of 71 higher than 1 of 71 other Crohn Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn Disease 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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Related registry views

Source: ClinicalTrials.gov NCT03194529, the US trial registry maintained by the National Library of Medicine. NCT03194529 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.