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

Summary

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.

Timeline

Start

2022-12-01

Primary completion

2024-12-01

Completion

2025-12-01

Drugs

Indications