Clinical trial NCT02720900: Prebiotic Intervention for Autism Spectrum Disorders
Official title: Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: Clasado Limited
Sponsor class: INDUSTRY
Collaborators: name: University of Reading
First posted: 2016-03-28
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: effect on faecal microbiota composition using pyrosequencing
timeFrame: change from baseline in microbiota composition to the end of treatment (6 months)
measure: effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy
timeFrame: change from baseline in microbiota activity to the end of treatment (6 months)
Secondary outcomes:
measure: questionnaire as a measure of bowel function
timeFrame: measured weekly for 6 months
measure: questionnaire as a measure of mood
timeFrame: monthly for 6 months
measure: questionnaire as a measure of behaviour
timeFrame: monthly for 6 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berks
Study officials:
affiliation: Clasado Research Services
name: Jelena Vulevic, phd
role: STUDY_CHAIR
References:
citation: 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.