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NCT03747718

Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children

Withdrawn Phase 1 Last updated 14 April 2023
What this trial tests

Phase 1 trial testing Fecal Microbiota Transplantation in Crohn Disease. Withdrawn.

Timeline
1 December 2022
Primary endpoint
1 December 2024
1 December 2025

Quick facts

Lead sponsorStanford University
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingtriple
Primary purposetreatment
Start date1 December 2022
Primary completion1 December 2024
Estimated completion1 December 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

Adults 2 to 25, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

NCT02108821 Primary goal: -To determine the safety of fecal transplant by colonoscopy and retention enemas for induction followed by maintenance retention fecal vs. placebo enemas in children and young adults with uncomplicated mild-moderately active Crohn's disease. Secondary goals: * Assess efficacy of this induction regimen followed by maintenance fecal or placebo transplants in responders. The efficacy will be assessed by clinical evaluation and fecal calprotectin that is a non-invasive biomarker. * Correlate subject's baseline microbiome findings with likelihood for response to FMT induction therapy. * Follow the chronological microbiome shifts after transplant and correlate with response using clinical and calprotectin assessment in the two groups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
    Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z
  2. Fecal microbiota transplantation beyond Clostridioides difficile infections.
    Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066

Verify or expand the search:

Other trials of Fecal Microbiota Transplantation

Trials testing the same drug.

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

Other Stanford University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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