Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- The efficacy of FMT in pediatric FGID
研究概览
简要总结
Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
排除标准
- •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
研究组 & 干预措施
Conventional drug intervention
Conventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules.
干预措施: Conventional drugs (Drug)
fecal microbiota transplantation
Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules
干预措施: FMT (Biological)
结局指标
主要结局
The efficacy of FMT in pediatric FGID
时间窗: 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
时间窗: 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)
The composite response
时间窗: 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.
次要结局
- Mean number of bowel movements per week(4 weeks and 8weeks)
- Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)(4 weeks and 8 weeks)
- gut microbial(4 weeks and/or 8 weeks)
- Adverse events(2 weeks , 4 weeks and 8 weeks)
- Change in Pittsburgh sleep quality index (PSQI)(4 weeks and 8 weeks)
- Bristol stool scale(4 weeks and 8 weeks)
- Adverse events(4 weeks and 8 weeks)
研究者
Biao Zou
associate professor
Tongji Hospital