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

Sponsor

Biao Zou (Other)

Overall Status

Recruiting

CT.gov ID

NCT05753774

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Safety and efficacy of FMT in Pediatric Functional

Condition or Disease	Intervention/Treatment	Phase
Functional Gastrointestinal Disorders	Biological: FMT	N/A

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, to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fecal microbiota transplantation fecal microbiota transplantation	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 2courses, 3 times per courses

Arm

Intervention/Treatment

Experimental: fecal microbiota transplantation

fecal microbiota transplantation

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 2courses, 3 times per courses

Outcome Measures

Primary Outcome Measures

The efficacy of FMT in pediatric FGID [4 weeks]
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.
Change in Pittsburgh sleep quality index (PSQI) [4 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
Adverse events [4 weeks]
All possible adverse events: fever, abdominal pain, infectious diseases and others

Secondary Outcome Measures

self-reported severity of pain [4 weeks]
change in self-reported severity of pain is defined as at least two Faces Pain Score improvement at the end of the study compared to the baseline. The method uses six facial expressions, using different expressions ranging from smiling to crying to describe pain. 0: Very pleasant, no pain; 10: Severe pain
Mean number of bowel movements per week [4 weeks]
change in the mean number of bowel movements per week
Bristol stool scale [4 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.
Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire [4 weeks]
The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life.
gut microbial [4 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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