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

NCT ID: NCT05151601

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DIETARY_SUPPLEMENT

2 x sachets per day

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2 x sachets per day

Interventions

Experimental

2 x sachets per day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2 x sachets per day

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter SW Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

University of Queensland, Child Health Research Centre

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

2020-11-30-Auts

Identifier Type: -

Identifier Source: org_study_id