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Fecal Microbiome Transplant
Sponsor: Judith Kelsen
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
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