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

Study Overview
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Brief Summary
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Safety and efficacy of FMT in Pediatric Functional

Detailed Description
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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.

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

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Biological: FMT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fecal microbiota transplantation<br>fecal microbiota transplantation | Biological: FMT<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8weeks | 
| self-reported severity of pain | change in self-reported severity of pain is defined as at least two Faces Pain Score | 4 weeks and 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8weeks | 
| Mean number of bowel movements per week | change in the mean number of bowel movements per week | 4 weeks and 8weeks | 
| 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 8weeks | 
| 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 8weeks | 
| 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 | 
| Adverse events | All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy