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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-08-01

Brief Summary

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Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

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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. 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

Conditions

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Functional Gastrointestinal Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Children with functional gastrointestinal disease were divided into two groups, one group was given FMT combined with conventional drug intervention, and the other group was given conventional drug intervention, including: probiotics and/or omeprazole, and/or cyproheptadine, and/or amitriptyline, and/or moxapride

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fecal microbiota transplantation

Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules

Group Type ACTIVE_COMPARATOR

FMT

Intervention Type 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

Conventional drug intervention

Conventional drugs include: probiotics and omeprazole, and cyproheptadine and moxapride.

Group Type SHAM_COMPARATOR

Conventional drugs

Intervention Type DRUG

Conventional drugs include probiotics and omeprazole, and cyproheptadine and moxapride

Interventions

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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

Intervention Type BIOLOGICAL

Conventional drugs

Conventional drugs include probiotics and omeprazole, and cyproheptadine and moxapride

Intervention Type DRUG

Other Intervention Names

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fecal microbiota transplantation cyproheptadine

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes