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

ConditionFunctional Gastrointestinal Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorBiao Zou

About this trial

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FMT

    Biological/Vaccine

    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

  • Conventional drugs

    Drug

    Conventional drugs include probiotics and omeprazole, and cyproheptadine and moxapride

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: fecal microbiota transplantationActive comparator 1 intervention
Group B: Conventional drug interventionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks and 8 weeks
2

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)

Time frame
4 weeks and 8 weeks

Secondary outcomes

1

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

Time frame
4 weeks and 8 weeks
2

Mean number of bowel movements per week

change in the mean number of bowel movements per week

Time frame
4 weeks and 8weeks
3

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.

Time frame
4 weeks and 8 weeks
4

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.

Time frame
4 weeks and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biao Zou

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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