Prebiotic Intervention for Autism Spectrum Disorders

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720900
• Other study ID #: ASD2015
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: February 14, 2018
• Start date: September 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2018
• Source: Clasado Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Dietary Supplement:
• B-GOS
1.8 g/day for 6 weeks
• Maltodextrin
1.8 g/day for 6 weeks

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berks

Sponsors (2)

Lead Sponsor	Collaborator
Clasado Limited	University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on faecal microbiota composition using pyrosequencing	using pyrosequencing	change from baseline in microbiota composition to the end of treatment (6 months)
Primary	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	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
Secondary	questionnaire as a measure of mood	using monthly scores on questions related to mood and sleep patterns	monthly for 6 months
Secondary	questionnaire as a measure of behaviour	using monthly scores on questions related to behaviour	monthly for 6 months