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| Name | Class |
|---|---|
| University of Reading | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | powder, 1.8g/day |
|
| B-GOS | Active Comparator | powder, 1.8g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-GOS | Dietary Supplement | 1.8 g/day for 6 weeks |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jelena Vulevic, phd | Clasado Research Services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Reading | Berks | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30071894 | Derived | 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. |
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upon completion of the whole study, volunteers will be able to access their individual data following written request
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Maltodextrin | Dietary Supplement | 1.8 g/day for 6 weeks |
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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 |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |