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Completed

NCT Number: NCT02720900

Prebiotic Intervention for Autism Spectrum Disorders

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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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berks, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-GOS

Dietary Supplement

1.8 g/day for 6 weeks

Other names: Bimuno

Maltodextrin

Dietary Supplement

1.8 g/day for 6 weeks

Other names: Corn Starch

Primary outcomes

  1. effect on faecal microbiota composition using pyrosequencing

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

    using pyrosequencing

  2. effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy

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

    using nuclear magnetic resonance spectroscopy

Secondary outcomes

  1. questionnaire as a measure of bowel function

    Time frame: measured weekly for 6 months

    using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating

  2. questionnaire as a measure of mood

    Time frame: monthly for 6 months

    using monthly scores on questions related to mood and sleep patterns

  3. questionnaire as a measure of behaviour

    Time frame: monthly for 6 months

    using monthly scores on questions related to behaviour

Sponsors and collaborators

Lead sponsor

Clasado Limited

Industry

Collaborators

  • University of Reading

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 28, 2016
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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