The Effect of a Combination of Human Milk Oligosaccharides (HMOs) and Probiotics on Behavioural Change in Children With Autism Spectrum Disorder (ASD).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Behaviour Change
研究概览
简要总结
This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.
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
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5.00 years to 12.99 years.
- •A confirmed diagnosis of ASD or Pervasive Developmental Disorders (PDD) including autistic disorder, Asperger's disorder (AS); PDD not otherwise specified (PDD-NOS); and atypical autism.
排除标准
- •Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
- •Bowel surgery or short bowel syndrome
- •Participants who have a diagnosed cow milk protein allergy.
- •Participants who suffer from the conditions listed below or who are taking any of the following medications or supplements:
- •antibiotics or antifungals in the last two months
- •probiotic supplements in the last two months
- •immunocompromised or severely ill
- •genetic disorders (e.g. Fragile X Syndrome)
- •chronic health conditions such as diabetes, heart disease or an eating disorder.
结局指标
主要结局
Behaviour Change
时间窗: Baseline and post-Phase 1A (week 8/9)
Changes in parent/guardian targeted behaviours as measured by the Parent Targeted Symptom Visual Analogue Scale (PTSVAS). The PTSVAS tool requests parents/guardians report their top three (3) target behaviours (behaviours of concern) on a Visual Analogue Scale (VAS). The VAS is a horizontal line of 100mm in length, with each end defined as the extreme limits of the behaviour of concern ("best" to "worst"), to be measured from left to right. The parents will score the behaviour by placing a mark on the VAS at baseline and post-intervention. Each mark will be measured on the scale of 0-100mm and the change from baseline to post-intervention noted.
Behaviour change
时间窗: Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18)
Changes in behavioural symptoms as measured by the Irritability sub-scale of the Aberrant Behavior Checklist - Community (Version 2) (I-ABC). The ABC 58-item parent-rated questionnaire and consists of five subscales, including: 1) irritability (15 items); 2) lethargy/social withdrawal (16 items); 3) stereotypic behaviour (7 items); 4) hyperactivity/noncompliance (16 items); and 5) inappropriate speech (4 items). Each item is scored as 0=never a problem, 1=slight problem, 2=moderately serious problem, or 3=severe problem. The score range is 0-174, with a higher score indicating greater severity or difficulties.
次要结局
- Change in GI Symptom Severity(Baseline and post-Phase 1A (week 8/9))
- Change in urinary serotonin concentration(Baseline and post-Phase 1A (weeks 8/9))
- Change in Anxiety Levels(Baseline and post-Phase 1A (week 8/9))
- Change in salivary cortisol levels(Baseline and post-Phase 1A (weeks 8/9))
- Change in the Gut Microbiome(Baseline and post-Phase 1A (week 8/9))
- Change in Quality of Life(Baseline and post-Phase 1A (week 8/9))
- Change in Stool Consistency(Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) .)
- Change in stool short chain fatty acids levels(Baseline and post-Phase 1A (weeks 8/9))