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)

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: B-GOS

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berks
    • Reading, Berks, United Kingdom
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Maltodextrin; powder, 1.8g/day	Dietary supplement: Maltodextrin; 1.8 g/day for 6 weeks; Other Names: Corn Starch
Active Comparator: B-GOS; powder, 1.8g/day	Dietary supplement: B-GOS; 1.8 g/day for 6 weeks; Other Names: Bimuno

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clasado Limited
• Collaborators: University of Reading
• Investigators: Study Chair: Jelena Vulevic, phd, Clasado Research Services

Publications and helpful links

General Publications

• Grimaldi R, Gibson GR, Vulevic J, Giallourou N, Castro-Mejia JL, Hansen LH, Leigh Gibson E, Nielsen DS, Costabile A. A prebiotic intervention study in children with autism spectrum disorders (ASDs). Microbiome. 2018 Aug 2;6(1):133. doi: 10.1186/s40168-018-0523-3.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: ASD2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: upon completion of the whole study, volunteers will be able to access their individual data following written request