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

NCT05753774 | Recruiting

• 1 other identifier: 63639582
• Study Type: interventional
• Target: 100
• 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 (2)

• The efficacy of FMT in pediatric FGID

  change in Gastrointestinal Symptom Rating Scale (GSRS), validated scale of GI symptoms. 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.

  4 weeks and 8 weeks

• self-reported severity of pain

  change in self-reported severity of pain is defined as at least two Faces Pain Score (Wong-Baker Pain Rating Scale;0-no hurt,10-hurts worst for pain)

  4 weeks and 8 weeks

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 moxapride.

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 moxapride

Also known as: cyproheptadine

Conventional drug intervention

Eligibility Criteria

• Age: 1 Year - 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

RECRUITING

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

Central Study Contacts

Biao Zou, MD

CONTACT

15871365900; 464021552@qq.com

Sainan Shu, MD, PhD

CONTACT

13886011908; shusainan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Model Details: Children with functional gastrointestinal disease were divided into two groups, one group was given FMT combined with conventional drug intervention, and the other group was given conventional drug intervention, including: probiotics and/or omeprazole, and/or cyproheptadine, and/or amitriptyline, and/or moxapride

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 3, 2023
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)