Results of the Action of a Combination of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language, Behavioral Evolution and Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Microbiota
研究概览
简要总结
The study included boys and girls with neurodevelopmental disorders between the ages of 3 and 16 years, belonging to two educational centers in Madrid, attended by children with this type of disorder. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them. The study will be randomized, so that probiotics will be administered to some children and placebos to others; and blinded, so that neither the patient nor his family will know whether probiotic or placebo is administered.
The aim of this project is to study the results obtained on microbiota, intestinal permeability, language, behavior and learning of a probiotic combination that will be administered to children in several educational centers that care for children with neurodevelopmental disorders for 5 months.
详细描述
The trial was conducted in 4 stages:
- Probiotic development, which will be randomized, so that some children will receive the probiotic and others placebos, and blinded, so that neither the children nor their relatives will know whether they take placebo or probiotic.
- Initial survey to rule out digestive symptoms and resolve possible doubts. Data will be collected on type of housing, location, number of family members, and others. Collection of fecal samples prior to the administration of the probiotic, to carry out a microbiota and intestinal permeability study.
- Administration of the probiotic preparation or placebo to the subjects for 5 months. Monitoring will be done within each center and in the middle of the treatment the doctors will make a face-to-face visit to see the children.
- In the last phase a new online visit is made where a complete clinical history and a survey to rule out digestive symptomatology are evaluated. A neurocognitive evaluation is also done using the SENA behavioral test. New fecal samples are collected for a microbiota and intestinal permeability study following the same procedure as in the second stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with neurodevelopmental disorders between 3 and 16 years old
- •Similar characteristics in terms of type of food
排除标准
- •Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation
结局指标
主要结局
Microbiota
时间窗: Through study completion, an average of 6 months
Examination of fecal samples
Intestinal permeability
时间窗: Through study completion, an average of 6 months
Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms
次要结局
- Analyze improvement in language, behavior and learning(Through study completion, an average of 6 months)
- Analyze the outcome in pre-existing digestive disorders(Through study completion, an average of 6 months)
- Analyze the composition of the microbiota and its improvement(Through study completion, an average of 6 months)