Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Parent Global Impressions of Autism
研究概览
简要总结
This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.
详细描述
SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.
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
- 30 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
- •Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.
- •Children and adults ages 2.5-75 years
排除标准
- •Antibiotic use in the last two months (not counting topical antibiotics)
- •Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
研究组 & 干预措施
Treatment Group
Each participant receives a customized probiotic based on the results of the test of their microbiota
干预措施: Flore (Dietary Supplement)
结局指标
主要结局
Parent Global Impressions of Autism
时间窗: change in score between baseline and 3 months
questionnaire which assesses 20 different autism-related symptoms on a 7-point scale
Parent Global Impressions of Autism - Change
时间窗: change in score between baseline and 3 months
The PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better) Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline).
次要结局
- Social Responsiveness Scale(change in score between baseline and 3 months)
- Gastrointestinal Symptom Rating Scale(change in score between baseline and 3 months)
研究者
James B Adams
President's Professor
Arizona State University