Prebiotic Intervention for Autism Spectrum Disorders

Not Applicable

Completed

• Conditions: Autism
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: B-GOS

• Registration Number: NCT02720900
• Lead Sponsor: Clasado Limited

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Primary Completion: 2016-09
• Study Completion: 2017-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	powder, 1.8g/day
B-GOS	B-GOS	powder, 1.8g/day

Primary Outcome Measures

Name	Time	Method
effect on faecal microbiota composition using pyrosequencing	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	change from baseline in microbiota activity to the end of treatment (6 months)	using nuclear magnetic resonance spectroscopy

Secondary Outcome Measures

Name	Time	Method
questionnaire as a measure of bowel function	measured weekly for 6 months	using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating
questionnaire as a measure of mood	monthly for 6 months	using monthly scores on questions related to mood and sleep patterns
questionnaire as a measure of behaviour	monthly for 6 months	using monthly scores on questions related to behaviour

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berks, United Kingdom