NCT05321758

Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Accepted

Summary

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

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 as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
DRUG	Immunosuppressive Agents	hormones, azathioprine, thalidomide

Timeline

• Start date: 2020-03-22
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-04-11
• Last updated: 2025-04-11

Locations

1 site across 1 country: China