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

Biao Zou

Status: Enrolling

Conditions: Functional Gastrointestinal Disorders

Treatments: Drug: Conventional drugs; Biological: FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT05753774

63639582

Details and patient eligibility

About

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

Full 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, 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

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

fecal microbiota transplantation

Active Comparator group

Description:

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

Treatment:

Biological: FMT

Conventional drug intervention

Sham Comparator group

Description:

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

Treatment:

Drug: Conventional drugs