A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
研究概览
简要总结
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.
详细描述
Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection.
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)
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 3-11 years old
- •Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- •Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
- •With guardians who can fully understand the informed consent and voluntarily sign the written informed consent
排除标准
- •Antibiotics or probiotics used within 1 mont
- •Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
- •Medications related to mental disorders or depression
- •Relying on tube feeding
- •Swallowing dysfunction that unable to take capsules
- •History of severe allergies
- •Paticipation in other clinical studies within 4 weeks
- •Poor compliance and have difficulty in completing follow-up.
结局指标
主要结局
Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
时间窗: week 12
This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points.
次要结局
- Changes in Childhood Autism Rating Scale(CARS) before and after treatment(week 0,4,8,12,24)
- Changes in Social Responsiveness Scale(SRS) before and after treatment(week 0,4,8,12)
- Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment(week 0,4,8,12, 24)
- Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment(week 0,12)
- Changes in Self-Rating Anxiety Scale(SAS) before and after treatment(week 0,4,8,12)
- Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment(week 0,4,8,12)
- Changes in gut microbiota of children with autism before and after treatment(week 0,12)
- Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment(week 0,4,8, 24)
研究者
Yanling Wei
Associate director / Associate professor
Third Military Medical University