Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
Autism Spectrum Disorder, Neurodevelopmental Disorders, Anxiety
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Gut microbiome, Behaviour
Eligibility Criteria
Inclusion Criteria:
- Aged 5.00 years to 12.99 years.
- A confirmed diagnosis of ASD or Pervasive Developmental Disorders (PDD) including autistic disorder, Asperger's disorder (AS); PDD not otherwise specified (PDD-NOS); and atypical autism.
Exclusion Criteria:
- Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
- Bowel surgery or short bowel syndrome
- Participants who have a diagnosed cow milk protein allergy.
Participants who suffer from the conditions listed below or who are taking any of the following medications or supplements:
- antibiotics or antifungals in the last two months
- probiotic supplements in the last two months
- immunocompromised or severely ill
- genetic disorders (e.g. Fragile X Syndrome)
- chronic health conditions such as diabetes, heart disease or an eating disorder.
Sites / Locations
- University of Queensland, Child Health Research Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
HMOs + Probiotics
Placebo
Dosing: A total daily dose of 2 x sachets (6g/day) Product Comprised of: 2.5g of a proprietary blend of human milk oligosaccharides combined with 20 billion CFUs of a mixture of Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium animalis spp. lactis, and Bifidobacterium longum. Mode of administration: oral.
Dosing: A total daily dose of 2 x sachets (6g/day)u (8 weeks of phase 1A). Product: powdered maltodextrin. Mode of administration: oral.