NCT05753774

Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders

Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Biao Zou · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Accepted

Summary

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Detailed description

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions

Conditions

• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
BIOLOGICAL	FMT	FMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut. FMT was given 1-3courses, 3-6 times per courses
DRUG	Conventional drugs	Conventional drugs include probiotics and omeprazole, and cyproheptadine and moxapride

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-03-03
• Last updated: 2025-09-10

Locations

1 site across 1 country: China