Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism

The Effect of a Combination of Human Milk Oligosaccharides (HMOs) and Probiotics on Behavioural Change in Children With Autism Spectrum Disorder (ASD).

This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.

Inclusion Criteria:

1. Aged 5.00 years to 12.99 years.
2. 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:

1. Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.

2. Bowel surgery or short bowel syndrome

3. Participants who have a diagnosed cow milk protein allergy.

4. 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.