Prebiotic intervention for ASD, version 3
Research type
Research Study
Full title
Effect of a prebiotic (B-GOS) supplementation on microbiota and gastrointestinal (GI) symptoms in children with autism spectrum disorders (ASD)
IRAS ID
179314
Contact name
Glenn R. Gibson
Contact email
Clinicaltrials.gov Identifier
15/SC/0230, Full REC
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
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. Studies to investigate such possibilities have led to inconsistent results and no studies have yet linked imbalances in the gut microbiota with imbalances of gut microbiota products.
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, aged 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 treatments 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.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0230
Date of REC Opinion
15 May 2015
REC opinion
Unfavourable Opinion