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临床试验/NCT02720900
NCT02720900已完成不适用

Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)

Clasado Limited1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
effect on faecal microbiota composition using pyrosequencing

研究概览

简要总结

The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders.

详细描述

Children with ASD have a higher incidence of dietary and/or bowel problems than typically developing children. it has been postulated that imbalances in the gut bacteria and/or metabolites present in the gut may be a contributing factor to these symptoms, with potentially bad (toxin-producing) bacteria colonising the gut. Certain carbohydrates (so-called 'prebiotics') are not digested by the human gut and they provide food for beneficial bacteria and thus they improve the composition by preventing the growth of bad bacteria. Individuals could therefore benefit from these safe and effective dietary interventions to maintain the healthy gut bacteria and overall health. This study is being carried out to establish the effect of one such prebiotic, called galactooligosaccharide (B-GOS) on the relative balance of gut bacteria and metabolites in children with ASD. The aim is to enrol 42 children, ages 5-10 with formal ASD diagnosis and with signed informed consent from their parents, into double-blind, placebo controlled, parallel study. The trial will last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up). Children will be required to take food supplement daily during the treatment period and their parents will collect stool, saliva and urine samples. Various questionnaires will also be used for assessments. Children will not be required to make other extra changes to their diet, medication or lifestyle.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 5-10 years with formal ASD diagnosis
  • children's parent or guardian has given written informed consent to participate and is willing to participate in the entire study

排除标准

  • consumption of antibiotics, prebiotic or probiotics in the last 4 weeks prior to or during the study
  • participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
  • undergone surgical resection of any part of the bowel

研究组 & 干预措施

B-GOS

Active Comparator

powder, 1.8g/day

干预措施: B-GOS (Dietary Supplement)

Maltodextrin

Placebo Comparator

powder, 1.8g/day

干预措施: Maltodextrin (Dietary Supplement)

结局指标

主要结局

effect on faecal microbiota composition using pyrosequencing

时间窗: change from baseline in microbiota composition to the end of treatment (6 months)

using pyrosequencing

effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy

时间窗: change from baseline in microbiota activity to the end of treatment (6 months)

using nuclear magnetic resonance spectroscopy

次要结局

  • questionnaire as a measure of bowel function(measured weekly for 6 months)
  • questionnaire as a measure of mood(monthly for 6 months)
  • questionnaire as a measure of behaviour(monthly for 6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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