Effect of a Casein and Gluten Free Diet on Gastrointestinal Symptoms, Clinical Variables and Gut Microbiota Composition in Mexican Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis
研究概览
简要总结
Assess the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder.
详细描述
The objective of this quasi-experimental pre-post study with time series is to evaluate the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder. The main question it aims to answer is:
Does a casein free and gluten free diet promote a reduction in gastrointestinal symptoms, an improvement in clinical variables, and a state of eubiosis in the composition of the intestinal microbiota in Mexican children with autism spectrum disorder?
Participants will undergo:
An intervention of a casein-free and gluten-free diet for 3 months. Sample collection before and after the nutritional intervention. Clinical evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 4-10 years old diagnosed with autism spectrum disorder using the criteria established in the ADOS scale and the CARS.
排除标准
- •Children who have received:
- •Antibiotics
- •Antimycotics
- •Probiotic supplements
- •Prebiotic supplements
- •Any medication that may alter the microbial composition of the patient, minimum one month prior to sampling.
- •Children on a strict dietary regimen other than a casein-free and gluten-free diet.
- •Children with celiac disease or who present any gluten-related disorder.
- •Children with allergy to dairy products.
结局指标
主要结局
Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis
时间窗: 12 weeks
The composition of the intestinal microbiota will be sequenced, and gastrointestinal symptoms will be characterized before and after the nutritional intervention.
次要结局
未报告次要终点
研究者
Nora Magdalena Torres Carrillo
PH.D. In Biomedical Sciences, Tenured Research Professor A
University of Guadalajara