Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
研究概览
简要总结
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD traits. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.
详细描述
Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents with an established diagnosis of ADHD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
- •Age 3-17 years.
- •Received stable treatments for ≥1 month preceding WMT
排除标准
- •Their guardian could not understand the questionnaires or provide informed consent.
- •Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
- •Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
- •Accompanied with other life-threatening disorders required emergency treatment.
- •Unable to tolerate colonoscopy or anesthesia.
研究组 & 干预措施
Washed microbiota transplantation
WMT
干预措施: Washed Microbiota Transplantation (Drug)
结局指标
主要结局
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
时间窗: baseline, 1 month,3 months, 6 months post transplantation
ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms.
Changes in the Autism Behavior Checklist (ABC) in ASD children
时间窗: baseline, 1 month , 3 months, 6 months post transplantation
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score\> 67 strongly suggests the presence of autism.
次要结局
- Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.(Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.)
- The Sleep Disturbance Scale for Children(baseline, 1 month, 3 months, 6 months post transplantation)
- Clinical Global Impressions-Improvement(baseline, 1 months, 3 months, 6 months post transplantation)
- Conners' Parent Rating Scale-Revised (CPRS-R)(At baseline, 1 month, 3 months and 6 months after WMT)
- The Gastrointestinal Symptom Rating Scale(baseline, 1 month, 3 months, 6 months post transplantation)
- The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)(At baseline, 1 month, 3 months and 6 months after WMT)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University