Nutritional Intervention in Children With ASD and/or ADHD: Randomized Controlled Trial With Probiotics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Continuous Performance Test (CPT 3 or CPT-K 2)
研究概览
简要总结
Based on alterations in the intestinal microbiota in children with ASD and the high comorbidity between ASD and ADHD, the aim of this project was to assess whether the administration of probiotics with strains related to the production of the neurotransmitters dopamine and GABA had a positive effect on social behavior, attention, and behavior.
详细描述
We hypothesized to find differences in the composition and / or function of the microbiota of the gastrointestinal tract of children with ASD and / or ADHD. We consider that the intervention with probiotics (and specifically with GABA and dopamine producing strains), can modify the composition and / or function of the GIT microbiota and change the child's behavior, partially reducing the symptoms of attention deficit, anxiety, irritability, impulsivity and restlessness associated with diagnoses and consequently, we believe that it could improve the quality of life for children and their families. Apart from the clinical evaluation of the disorder and associated psychopathological symptoms and neuropsychological deficit, the diet, lifestyle and anthropometric characteristics of the child will be evaluated, which can influence the composition and / or function of gut the microbiota.
The sample that will be part of the study will be 80 children, 40 with a diagnosis of ASD and 40 with a diagnosis of ADHD. These children will randomly receive placebo or probiotic intervention for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
ABBiotics has been the producer of probiotics and who knows the masking
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental informed consent,
- •ASD and ADHD will meet the DSM diagnoses (edition IV-TR or 5) criteria
- •Ages between 5 and 16 years
- •To complete period (12weeks) of taking the probiotic
排除标准
- •Having suffered adverse effects in the previous administration of probiotics
- •Being on probiotics 3 months before the start of the intervention
- •To suffer any medical illness incompatible with the administration of probiotics
- •Having intolerances or allergies to the excipient of the treatment (probiotic or placebo)
- •Taking antibiotics in the start of the intervention.
结局指标
主要结局
Continuous Performance Test (CPT 3 or CPT-K 2)
时间窗: 12 weeks
Measures attention and inhibitory control
Behavior Rating Inventory of Executive Function (BRIEF-2)
时间窗: 12 weeks
Assess severity ADHD symptoms answered by parents
Social Responsiveness Scale™, Second Edition
时间窗: 12 weeks
Assess severity of the ASD manifestations answered by parents
Conners scale
时间窗: 12 weeks
Assess severity ADHD symptoms answered by parents
次要结局
- Physical Activity (PAQ-C)(12 weeks)
- Gastrointestinal symptoms(12 weeks)
- Child Behavior Checklist (CBCL)(12 weeks)
研究者
Josefa Canals Sans
Professor
University Rovira i Virgili