NCT05321745

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Biao Zou · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

Detailed description

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	Standardized FMT	Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon

Timeline

• Start date: 2022-03-22
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2022-04-11
• Last updated: 2024-11-04

Locations

1 site across 1 country: China