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

Crohn Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT05321758
• Study type: Interventional
• Source: Tongji Hospital
• Contact: Biao Zou, MD
• Phone: 15871365900
• Email: 464021552@qq.com
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2020
• Completion date: June 30, 2025