drugset / Trial / NCT02636517

Fecal Microbiome Transplant

NCT02636517

Phase 1 Enrolling by invitation 250 enrolled Judith Kelsen
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD) The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.

Timeline

Start
2015-12
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Transplant Other / unclassified Other