NCT04939974Unknown不适用
Evaluation of the Efficacy of Oral Probiotics Supplementation in Children With Autism Spectrum Disorders (ASDs): a Randomized Double Blind, Placebo Controlled Trial
All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 100 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- change in childhood autism rating scale at 24 weeks as compared to baseline
研究概览
简要总结
One suitable probiotic packet will be administered to one group and placebo to another group of autism children and improvement in CARS will be monitored
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children diagnosed with Autistic Spectrum Disorders by DSM 5 criteria
- •Aged: 2-18 years.
- •Normal hearing (clinically or whenever required by Oto-acoustic emission / automated Brainstem evoked response audiometry)
- •Preferably patients from Delhi-NCR or ready to come for follow up -
排除标准
- •On standard treatment and care for more than 12 weeks
- •Received in last 12 weeks or currently on any complementary and/or alternate therapy including dietary therapy
- •Associated chronic systemic illness
- •Known allergy to any component of probiotic supplement
结局指标
主要结局
change in childhood autism rating scale at 24 weeks as compared to baseline
时间窗: 24 weeks
change in childhood autism rating scale at 24 weeks as compared to baseline
次要结局
未报告次要终点
研究者
Sheffali Gulati
Prof
All India Institute of Medical Sciences, New Delhi
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