Clinical trial NCT05753774: Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Functional Gastrointestinal Disorders;
FMT;
Safety; efficacy
efficacy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

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, 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

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of FMT in pediatric FGID
timeFrame: 4 weeks and 8 weeks
measure: self-reported severity of pain
timeFrame: 4 weeks and 8 weeks
Secondary outcomes:
measure: Change in Pittsburgh sleep quality index (PSQI)
timeFrame: 4 weeks and 8 weeks
measure: Mean number of bowel movements per week
timeFrame: 4 weeks and 8weeks
measure: Bristol stool scale
timeFrame: 4 weeks and 8 weeks
measure: Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)
timeFrame: 4 weeks and 8 weeks
measure: gut microbial
timeFrame: 4 weeks and/or 8 weeks
measure: Adverse events
timeFrame: 2 weeks , 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
Study officials:
affiliation: Tongji Hospital
name: Zhihua Huang
role: STUDY_DIRECTOR
References: