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Terminated

NCT Number: NCT05753774

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

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Why the study stopped: The study was terminated early because recruitment of eligible children with refractory functional abdominal pain disorders was slower than anticipated, and enrollment of the planned 50 participants was not feasible within the approved study period.
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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital

Wuhan, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: fecal microbiota transplantation

Conventional drugs

Drug

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

Other names: cyproheptadine

Primary outcomes

  1. The composite response

    Time frame: at weeks 4 and 8

    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.

Secondary outcomes

  1. Change in Pittsburgh sleep quality index (PSQI)

    Time frame: 4 weeks and 8 weeks

    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

  2. Mean number of bowel movements per week

    Time frame: 4 weeks and 8weeks

    change in the mean number of bowel movements per week

  3. Bristol stool scale

    Time frame: 4 weeks and 8 weeks

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

    Time frame: 4 weeks and 8 weeks

    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.

  5. gut microbial

    Time frame: 4 weeks and/or 8 weeks

    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.

  6. Adverse events

    Time frame: 4 weeks and 8 weeks

    All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others

Sponsors and collaborators

Lead sponsor

Biao Zou

Other

Registry information

Official study title

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

Acronym: FGIDs

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2023
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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