University of Reading
Reading, Berks, United Kingdom
NCT Number: NCT02720900
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.
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Notify Me5 year–10 year
All sexes
Interventional
Not applicable
Reading, Berks, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.8 g/day for 6 weeks
Other names: Bimuno
1.8 g/day for 6 weeks
Other names: Corn Starch
Time frame: change from baseline in microbiota composition to the end of treatment (6 months)
using pyrosequencing
Time frame: change from baseline in microbiota activity to the end of treatment (6 months)
using nuclear magnetic resonance spectroscopy
Time frame: measured weekly for 6 months
using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating
Time frame: monthly for 6 months
using monthly scores on questions related to mood and sleep patterns
Time frame: monthly for 6 months
using monthly scores on questions related to behaviour
Clasado Limited
Industry
Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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