A Clinical Study to Explore the Efficacy of Fecal Mircobiota Transplantation (FMT) in the Treatment of Childhood ASD Patients With Gastrointestinal Symptoms
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
To explore the efficacy of fecal microbiota transplantation (FMT) in improving the gastrointestinal symptoms and autism symptoms in patients diagnosed as autism spectrum disorder (ASD) comorbid with gastrointestinal symptoms.
详细描述
This trial is designed to reconstruct the intestinal micro-ecology of children with ASD by the interventional treatment of FMT. At the same time, combined with metagenomics and 16S rRNA sequencing techniques, the trial aims to study the efficacy of intestinal micro-ecology for the treatment of autism symptoms and the improvement of gastrointestinal problems and autism symptoms in autistic patients, and to explore potential new techniques for treating children with ASD.
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
- •Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);
- •Patients with moderate to severe gastrointestinal symptoms which are not life-threatening and do not require immediate surgery;
- •Patients aged 3-17 years, male or female;
- •Patients who are suitable for receiving oral FMT capsules, and able to swallow the capsules without chewing;
- •Patients who are able to complete the study as required by the trial protocol;
- •Patients without known immunodeficiency diseases;
- •Subjects and/or their guardians are able to fully understand the informed consent of the trial, and voluntarily sign the informed consent form.
- •Exclusion Criteria：
- •Patients diagnosed with severe malnutrition;
- •Patients depend on tube feeding (liquid food);
- •Patients with a serious gastrointestinal disease requiring immediate treatment (or life-threatening);
- •Patients with primary immunodeficiency disease during screening;
- •Patients with a single-gene disorder;
- •Patients with a history of severe allergies;
- •Patients with severe fever and/or serious infection within 7 days prior to enrollment;
- •Patients with renal insufficiency and liver dysfunction (or creatinine > 2 mg/dl, direct bilirubin > 2 mg/dl);
- •Subjects with congenital or acquired immunodeficiency or immunosuppression (e.g., neoplastic disease or organ transplant) who have received or are undergoing chemotherapy, or have been diagnosed with HIV;
- •Patients with inflammatory bowel disease, celiac disease, large intestine irritation or eosinophilia, esophagitis, eosinophilic gastroenteritis or similar diseases;
- •Subjects with severe sensory or motor disorders (e.g., blindness, deafness, seizures, cerebral palsy);
- •Patients who are participating in other clinical studies, or have received interventions in other interventional clinical studies within 4 weeks prior to enrollment.
排除标准
- 未提供
结局指标
主要结局
Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Baseline to 12 weeks
The Gastrointestinal Symptom Rating Scale (GSRS) is an interview-based rating scale consisting of 15 items for assessment of bowel function, which refers to the period of the previous week and requires a short time to fill and has easy-to-understand questions on gastrointestinal symptoms. Changes in the Gastrointestinal Symptom Rating Scale (GSRS) before and after treatment.
Childhood Autism Rating Scale (CARS)
时间窗: Baseline to 12 weeks
The CARS is a 15-item measure that clinicians complete based on observations from the child and subsequent interviews with the caregivers.The total score on the CARS reflects the symptom level of ASD with lower scores indicating minimal ASD symptoms and higher scores representing severe ASD symptoms. Changes in the Childhood Autism Rating Scale (CARS) before and after treatment.
次要结局
- Daily Stool Records (DSR)(From the treatment period to Week 12)
- Safety and Tolerability(Baseline to 12 weeks)
- Developmental Quotient/Intelligence Quotient Scale (DQ/IQ)(Baseline to 12 weeks)
- Long Term Safety Assessed Through Adverse Events([16, 20, 24 weeks])
- Autism Diagnostic Observation Schedule (ADOS)(Baseline to 12 weeks)
- Social Responsiveness Scale (SRS)(Baseline to 12 weeks)
- Clinical Global Impressions-Improvement (CGI-I) Scale(Baseline to 12 weeks)