NCT02636517

Fecal Microbiome Transplant

Fecal Microbiome Transplant in Pediatric C. Difficile

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Judith Kelsen · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile
• Inflammatory Bowel Disease
• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Timeline

• Start date: 2015-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2015-12-21
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States