Prebiotic Intervention for Autism Spectrum Disorders

Study Overview
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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.

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.

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

Conditions
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Autism

Intervention / Treatment
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* Dietary Supplement: B-GOS
* Dietary Supplement: Maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>powder, 1.8g/day | Dietary Supplement: Maltodextrin<br>* 1.8 g/day for 6 weeks<br>* Other names: Corn Starch;|
| Active Comparator: B-GOS<br>powder, 1.8g/day | Dietary Supplement: B-GOS<br>* 1.8 g/day for 6 weeks<br>* Other names: Bimuno;|

What is the study measuring?
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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 |