NCT02720900

Prebiotic Intervention for Autism Spectrum Disorders

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Clasado Limited · Industry
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Autism

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B-GOS	1.8 g/day for 6 weeks
DIETARY_SUPPLEMENT	Maltodextrin	1.8 g/day for 6 weeks

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2017-05-01
• First posted: 2016-03-28
• Last updated: 2018-02-15

Locations

1 site across 1 country: United Kingdom