Clinical trial

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

NCT05753774

Name

63639582

Description

Safety and efficacy of FMT in Pediatric Functional

Trial arms

Trial start

2022-08-01

Estimated PCD

2026-08-01

Trial end

2026-08-01

Status

Recruiting

Treatment

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

Arms:

fecal microbiota transplantation

Size

100

Primary endpoint

The efficacy of FMT in pediatric FGID

4 weeks and 8weeks

self-reported severity of pain

4 weeks and 8weeks

Eligibility criteria

Inclusion Criteria: * The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children Exclusion Criteria: * organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.) * other chronic disease * growth failure

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-10-12

1 organization

1 drug

1 indication

Organization

Biao Zou

Drug

FMT

Indication

Functional Gastrointestinal Disorders