Autism
Conditions
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.
Interventions
DIETARY_SUPPLEMENTB-GOS
1.8 g/day for 6 weeks
DIETARY_SUPPLEMENTMaltodextrin
1.8 g/day for 6 weeks
Sponsors
University of Reading
Clasado Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect on faecal microbiota composition using pyrosequencing | change from baseline in microbiota composition to the end of treatment (6 months) | using pyrosequencing |
| effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy | change from baseline in microbiota activity to the end of treatment (6 months) | using nuclear magnetic resonance spectroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire as a measure of bowel function | measured weekly for 6 months | using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating |
| questionnaire as a measure of mood | monthly for 6 months | using monthly scores on questions related to mood and sleep patterns |
| questionnaire as a measure of behaviour | monthly for 6 months | using monthly scores on questions related to behaviour |
Countries
United Kingdom
Outcome results
None listed