Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions-Improvement (CGI-I)
研究概览
简要总结
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism.
详细描述
Gut microbiota dysbiosis has been reported to play a critical role in the initiation and progression of neurodevelopmental disorders like ADHD via the gut-brain axis. Therapies targeting gut microbiota including including probiotics, prebiotics and fecal microbiota transplantation (FMT) might provide new insight into the management of ADHD. FMT has been reported to be a highly effective therapy to restore the gut microbiota dysbiosis by transferring gut microbiota from healthy donors to patients. The newly improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the FMT-standardization study group. FMT has shown treatment potential in several gut-brain axis-related disorders, such as amyotrophic lateral sclerosis and Parkinson's disease, promoting us to investigate its treatment potential for ADHD and its comorbidities. To date, only one case report showed a 22-year-old woman undergoing FMT primarily to treat recurrent Clostridioides difficile infection achieved ADHD symptoms alleviation. However, the efficacy of WMT for ADHD and the underlying mechanisms remain largely unexplored. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
- •Received stable treatments for ≥1 month preceding WMT;
- •Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT.
排除标准
- •Unable to understand the questionnaires or provide informed consent by the guardian;
- •Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis;
- •Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer;
- •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
Clinical Global Impressions-Improvement (CGI-I)
时间窗: 1 month, 3 months post transplantation
The Clinical Global Impressions-Improvement (CGI-I) evaluated by experienced clinician was used to assess the symptom changes relative to baseline, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). CGI-I = 1 or 2 was considered a clinical response.
次要结局
- change of the Sleep Disturbance Scale for Children (SDSC).(baseline, 1 month, 3 months post transplantation)
- change of the Gastrointestinal Symptom Rating Scale (GSRS) .(baseline, 1 month, 3 months post transplantation)
- the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome.(baseline, 1 month, 3 months post transplantation)
- intestinal barrier(baseline, 1 month, 3 months post transplantation)
- change of Swanson, Nolan and Pelham-IV (SNAP-IV).(baseline, 1 month, 3 months post transplantation)
- Conners' Parent Rating Scale-Revised(baseline, 1 month, 3 months post transplantation)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University