NCT05151601

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).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder
• Neurodevelopmental Disorders
• Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental	2 x sachets per day
OTHER	Placebo	2 x sachets per day

Timeline

• Start date: 2022-05-17
• Primary completion: 2023-04-16
• Completion: 2023-12-31
• First posted: 2021-12-09
• Last updated: 2023-06-28

Locations

1 site across 1 country: Australia