Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
- Conditions
- Functional Gastrointestinal Disorders
- Interventions
- Biological: FMTDrug: Conventional drugs
- Registration Number
- NCT05753774
- Lead Sponsor
- Biao Zou
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fecal microbiota transplantation FMT Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules Conventional drug intervention Conventional drugs Conventional drugs include: probiotics and omeprazole, and cyproheptadine and moxapride.
- Primary Outcome Measures
Name Time Method The efficacy of FMT in pediatric FGID 4 weeks and 8 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.
self-reported severity of pain 4 weeks and 8 weeks change in self-reported severity of pain is defined as at least two Faces Pain Score (Wong-Baker Pain Rating Scale;0-no hurt,10-hurts worst for pain)
- Secondary Outcome Measures
Name Time Method Mean number of bowel movements per week 4 weeks and 8weeks change in the mean number of bowel movements per week
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS) 4 weeks and 8 weeks 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.
gut microbial 4 weeks and/or 8 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.
Adverse events 2 weeks , 4 weeks and 8 weeks All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others
Change in Pittsburgh sleep quality index (PSQI) 4 weeks and 8 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
Bristol stool scale 4 weeks and 8 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.
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, China