Skip to content

Prebiotic supplement use, the gut microbiome and behaviour change in children with autism spectrum disorder (ASD).

Prebiotic supplement use, the gut microbiome and behaviour change in children with autism spectrum disorder (ASD).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000615189
Acronym
None
Enrollment
38
Registered
2019-04-24
Start date
2019-05-17
Completion date
2020-03-30
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This intervention study will assess the effect of prebiotic supplementation ßGOS on Quality of life, basal cortisol levels, social and mealtime behaviours, GI symptoms and sleep patterns in children aged 4 to 10 years with a clinical diagnosis of Autism Spectrum Disorder (ASD).

Interventions

We will conduct a 6-week double blind RCT in which the intervention group (25 children with a clinical diagnosis of ASD, aged 4 to 10 years) will be given a daily dose of 2.4g of prebiotic galacto-oligosaccharides (ßGOS) divided into 4 doses of 0.6g. Each dose is contained in a capsule which should be opened and the powder mixed into 100mls of fluid / drink. Compliance will be measured by counting returned capsules on completion of the intervention, and by a supplement diary which asks a tick fo

We will conduct a 6-week double blind RCT in which the intervention group (25 children with a clinical diagnosis of ASD, aged 4 to 10 years) will be given a daily dose of 2.4g of prebiotic galacto-oligosaccharides (ßGOS) divided into 4 doses of 0.6g. Each dose is contained in a capsule which should be opened and the powder mixed into 100mls of fluid / drink. Compliance will be measured by counting returned capsules on completion of the intervention, and by a supplement diary which asks a tick for each dose administered. The supplement is to be given under supervision of the parent / carer. A parent or carer of the child participant will attend 2 research visits, the first on day 1 (baseline) and the second on day 43 (completion) of the intervention. These visits will last 1 hour. During these visits, completed questionnaires and clinical samples will be collected (see attached protocol), and standardised dietary advice will be given by one paediatric dietitian (JP), focusing on promoting positive mealtime environments, reducing stress around mealtimes and focusing on small steps involving sensory acceptance of foods.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
4 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a formal diagnosis of ASD (presentation of medical letter of diagnosis), child participants aged between 4 and 10 years parent / carer english speaking naïve to dietary intervention involving prebiotic supplementation parents of participants must agree to all aspects of the protocol.

Exclusion criteria

no recent use (within last 3 months) of antibiotics no recently commenced prebiotics (within the past month) no recently commenced probiotics (within the past month) no new medications (or dose change) for anxiety, sleep or behaviour (within the past 2 months)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026