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ENROLLING BY INVITATION
NCT02636517
PHASE1

Fecal Microbiome Transplant

Sponsor: Judith Kelsen

View on ClinicalTrials.gov

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.

Official title: Fecal Microbiome Transplant in Pediatric C. Difficile

Key Details

Gender

All

Age Range

3 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2015-12

Completion Date

2027-12

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States