Actively Recruiting
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
Led by Biao Zou · Updated on 2025-09-10
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) in children with functional gastrointestinal disorders (FGIDs). FGIDs involve complex gut and brain interactions, including changes in gut bacteria and immune function. The study compares conventional drug treatments with FMT, exploring how altering gut bacteria might help manage these disorders in children aged 1 to 15. Participants receive either FMT or conventional drug treatments, which include probiotics, omeprazole, cyproheptadine, and moxapride. FMT is delivered through various routes such as the upper or lower digestive tract or oral capsules, given in 1 to 3 courses with 3 to 6 treatments per course. The study collects and compares data over time to assess treatment effects and monitors adverse reactions related to FMT. During the study, children are regularly assessed for treatment effectiveness and safety. Measurements include self-reported pain severity, sleep quality, bowel movement frequency, stool consistency, and symptom severity scales at 4 and 8 weeks. Gut microbial changes are also monitored alongside adverse events at multiple time points. The study allows close observation to understand how FMT affects pediatric FGID symptoms over time, with participation lasting at least 8 weeks.
CONDITIONS
Brief Title
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 15 years
- Diagnosis of functional gastrointestinal disorders according to Rome IV criteria
You will not qualify if you...
- Presence of organic gastrointestinal disease based on medical history and lab tests
- Presence of other chronic diseases
- Growth failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive either fecal microbiota transplantation (FMT) involving 1 to 3 courses with 3 to 6 treatments per course or conventional drug treatments including probiotics, omeprazole, cyproheptadine, and moxapride.
Visits at 2 weeks, 4 weeks, and 8 weeks for assessments and monitoring
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, China, 430030
Actively Recruiting
Research Team
B
Biao Zou, MD
S
Sainan Shu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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