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

NCT05753774 | Terminated Phase 3

• 1 other identifier: 027-63639582
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Conditions

Functional Gastrointestinal Disorders

Keywords

Functional Gastrointestinal Disorders;; FMT;; Safety; efficacy; efficacy

Outcome Measures

Primary Outcomes (1)

• The composite response

  Requiring a ≥50% reduction in GSRS score AND a ≥50% reduction in either the F-VAS or FPS-R score, with no addition of any non-permitted medications, was considered treatment success. For the GSRS, a clinician-administered semi-structured interview evaluating five domains (reflux, abdominal pain, diarrhea, constipation, and dyspepsia; total score range: 15-105) was conducted. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. For Faces Visual Analog Scale, patients rated their pain on an age-adapted 100-mm linear scale with cartoon facial gradients ("happy→neutral→distressed") for real-time pain intensity quantification (range: 0-100). For revised Wong-Baker Faces Pain Scale, a six-level behaviorally anchored scale (0-10) combined with vital sign monitoring (heart rate/blood pressure correlations) was used as a visual pain assessment tool.

  at weeks 4 and 8

Secondary Outcomes (6)

• Change in Pittsburgh sleep quality index (PSQI)

  4 weeks and 8 weeks

• Mean number of bowel movements per week

  4 weeks and 8weeks

• Bristol stool scale

  4 weeks and 8 weeks

• Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)

  4 weeks and 8 weeks

• gut microbial

  4 weeks and/or 8 weeks

Study Arms (2)

fecal microbiota transplantation

ACTIVE COMPARATOR

Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules

Biological: FMT

Conventional drug intervention

SHAM COMPARATOR

Conventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules.

Drug: Conventional drugs

Interventions

FMT BIOLOGICAL

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

Also known as: fecal microbiota transplantation

fecal microbiota transplantation

Conventional drugs DRUG

Conventional drugs include probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules

Also known as: cyproheptadine

Conventional drug intervention

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children

You may not qualify if:

• 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

Sponsors & Collaborators

• Biao Zou: lead

Study Sites (1)

Tongji Hospital

Wuhan, 430030, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Fecal Microbiota Transplantation; Cyproheptadine

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Zhihua Huang

  Tongji Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Model Details: Model Description

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 3, 2023
• Study Start: April 3, 2023
• Primary Completion: January 5, 2026
• Study Completion: March 9, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-05

Locations

CN (1)