The Effect of a Multispecies Probiotics on Autism Symptoms in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The Autism Spectrum Rating Scales (ASRS)
研究概览
简要总结
In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms, quality of life, gastrointestinal symptoms, sleep disturbances, parental stress levels and urinary p-cresol concentrations in children with Autism Spectrum Disorder aged 7 to 15 years.
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and ten children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10^9 colony forming units per dose consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200.
The primary outcome will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS). The secondary outcomes will include: the quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A), evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.
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
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).
- •Children either not taking any medication or receiving the same medication for the last 2 months.
- •Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.
排除标准
- •Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
- •Use of probiotics or synbiotics within the previous 2 months.
- •History of intolerance or allergy to probiotics, synbiotics or any other study product component.
- •Surgery with bowel resection or short bowel syndrome.
- •Children with severe immunodeficiency.
研究组 & 干预措施
Multispecies probiotics group
55 participants
干预措施: Multispecies probiotics (Dietary Supplement)
Control group
55 participants
干预措施: Placebo (Other)
结局指标
主要结局
The Autism Spectrum Rating Scales (ASRS)
时间窗: 0-3 months
Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.
次要结局
- The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)(0-3 months)
- Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)(0-3 months)
- The Quality of Life in Autism Part A (QoLA-A)(0-3 months)
- Gastrointestinal Symptom Rating Scale (GSRS)(0-3 months)
- P-cresol levels in urine samples(0-3 months)