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

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

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Study Overview

• Status: Terminated
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Biological: FMT; Drug: Conventional drugs

Detailed Description

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Wuhan, China, 430030
    • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fecal microbiota transplantation; Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules	Biological: 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; Other Names: fecal microbiota transplantation
Sham Comparator: Conventional drug intervention; Conventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules.	Drug: Conventional drugs; Conventional drugs include probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules; Other Names: cyproheptadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of bowel movements per week	change in the mean number of bowel movements per week	4 weeks and 8weeks
Change in Pittsburgh sleep quality index (PSQI)	PSQI assesses sleep quality in children. A higher score indicates poorer sleep quality. The PSQI will be assessed from baseline to 1 weeks and from baseline to 1 month. PSQI is scored from 0 to 21 points. The higher the score, the worse the sleep. PSQI≥8 was poor sleep quality, and 7 was the cut-off value	4 weeks and 8 weeks
Bristol stool scale	Change in stool consistency assessed using the Bristol Stool Form Scale. The Bristol stool classification divides stool into seven categories. Types 1 and 2 indicate constipation; Types 3 and 4 are ideal for bowel movements, while types 5 to 7 indicate possible diarrhea.	4 weeks and 8 weeks
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)	IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.	4 weeks and 8 weeks
gut microbial	Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.	4 weeks and/or 8 weeks
Adverse events	All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others	4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: Biao Zou
• Investigators: Study Director: Zhihua Huang, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): March 9, 2026

Study Registration Dates

• First Submitted: February 11, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: efficacy; Functional Gastrointestinal Disorders;; FMT;; Safety; efficacy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Piperidines; Biological Therapy; Dibenzocycloheptenes; Benzocycloheptenes; Cyproheptadine; Fecal Microbiota Transplantation
• Other Study ID Numbers: 027-63639582

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No