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

Status: Unknown
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Australia
University of Queensland, Child Health Research Centre
Brisbane
Time Frame
Start Date: 2022-05-17
Completion Date: 2023-12-31
Participants
Target number of participants: 60
Treatments
Experimental: HMOs + Probiotics
Dosing: A total daily dose of 2 x sachets (6g/day)~Product Comprised of:~1. 2.5g of a proprietary blend of human milk oligosaccharides combined with~2. 20 billion CFUs of a mixture of Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium animalis spp. lactis, and Bifidobacterium longum.~Mode of administration: oral.
Placebo_comparator: Placebo
Dosing: A total daily dose of 2 x sachets (6g/day)u (8 weeks of phase 1A). Product: powdered maltodextrin. Mode of administration: oral.
Related Therapeutic Areas
Sponsors
Leads: The University of Queensland

This content was sourced from clinicaltrials.gov