Functional Gastrointestinal Disorders
Conditions
Keywords
Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy
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
Interventions
BIOLOGICALFMT
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 drugs include probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules
Sponsors
Biao Zou
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite response | at weeks 4 and 8 | Requiring a ≥50% reduction in GSRS score AND a ≥50% reduction in either the F-VAS or FPS-R score, with no addition of any non-permitted medications, was considered treatment success. For the GSRS, a clinician-administered semi-structured interview evaluating five domains (reflux, abdominal pain, diarrhea, constipation, and dyspepsia; total score range: 15-105) was conducted. 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. For Faces Visual Analog Scale, patients rated their pain on an age-adapted 100-mm linear scale with cartoon facial gradients ("happy→neutral→distressed") for real-time pain intensity quantification (range: 0-100). For revised Wong-Baker Faces Pain Scale, a six-level behaviorally anchored scale (0-10) combined with vital sign monitoring (heart rate/blood pressure correlations) was used as a visual pain assessment tool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mean number of bowel movements per week | 4 weeks and 8weeks | change in the mean number of bowel movements per week |
| 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. |
| 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 | 4 weeks and 8 weeks | All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others |
Countries
China
Contacts
STUDY_DIRECTORZhihua Huang
Tongji Hospital
Outcome results
None listed