Prebiotic Intervention for Autism Spectrum Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-31

Brief Summary

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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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Detailed Description

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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

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maltodextrin

powder, 1.8g/day

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

1.8 g/day for 6 weeks

B-GOS

powder, 1.8g/day

Group Type ACTIVE_COMPARATOR

B-GOS

Intervention Type DIETARY_SUPPLEMENT

1.8 g/day for 6 weeks

Interventions

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B-GOS

1.8 g/day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

1.8 g/day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bimuno Corn Starch

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No