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FMT in Pediatric Functional Gastrointestinal Disorders
NCT05753774Phase 3
Key facts
- Status
- Terminated
- Start
- Apr 2023
- Primary completion
- Jan 2026
- Countries
- 1
- Modality
- Live Biotherapeutic Products
- Conditions
- functional gastrointestinal disorders (FGID)
01
Overview
Phase 3, open-label trial of Fecal Microbiota Transplantation Capsule in functional gastrointestinal disorders (FGID) (2 arms). Primary endpoint: Composite response at 8 weeks. Started Apr 2023; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
fecal microbiota transplantation
Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules
Conventional drug intervention
Conventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules.
03
Who it enrols
Children with functional gastrointestinal disorders according to ROME IV criteria, excluding those with organic gastrointestinal disease, other chronic diseases, or growth failure.
04
Endpoints
Primary
Composite response
Secondary
Pittsburgh sleep quality index
Mean number of bowel movements per week
Bristol stool scale
Irritable bowel syndrome Symptom Severity Scale
Gut microbial
Adverse events
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