CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
FMTbiological
Likely dose
FMT 50gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03194529
NCT03194529Phase 2Completed
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Safety of FMT in Maintenance of Pediatric Crohn's Disease

Children's Hospital Los Angeles·interventional·Posted Jun 21, 2017·Updated Mar 13, 2020

In Brief

A Phase 2 clinical trial evaluating FMT for Crohn Disease and Pediatric Crohns Disease. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease, Pediatric Crohns Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartOct 9, 2017
Primary CompletionJun 30, 2019
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.0 years ago

Interventions

FMTbiological

Fecal Microbiota Transplantation, single dose, 50g of stool, delivered via standard of care upper endoscopy into jejunum.