Combined human milk oligosaccharides (HMOs) and probiotics intervention for children with autism.
To investigate the effect of a combination of human milk oligosaccharides (HMOs) and probiotics on behavioural changes in children with autism spectrum disorder (ASD)
University of Queensland
60 participants
May 16, 2022
Interventional
Conditions
Summary
The primary aim of the trial is to investigate if a combination of HMOs and probiotics can improve behavioural outcomes for children with autism spectrum disorder (ASD). This aim will be tested in a two-phase clinical trial. 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. The primary outcome will be measured by the irritability subscale of the Aberrant Behaviour Checklist (I-ABC), Other behavioural measurement tools to support the primary end-point include behavioural changes as measured by the Home Situational Questionnaire – ASD (HSQ-ASD) and the Parent-Targeted Symptom Visual Analogue Scale (PTSVAS), Secondary measures include change in: gastrointestinal symptom severity; stool consistency, quality of life; anxiety; gut (stool) microbial composition; stool short chain fatty acids levels; urinary serotonin concentration; and saliva cortisol levels. It is hypothesised that a combined supplement of HMOs and probiotics will improve behavioural outcomes for children with ASD via mechanisms of the microbiome-gut-brain axis. Evidence of efficacy will support additional research to investigate the gut micorbiome as a therapeutic target for this cohort.
Eligibility
Inclusion Criteria2
- 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.
Exclusion Criteria9
- Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
- Bowel surgery or short bowel syndrome.
- Participants with a diagnosed cow milk protein allergy.
- Participants who suffer from the conditions listed below or who are taking any of the following medications or supplements:
- a. antibiotics or antifungals in the last two months
- b. Probiotic supplements in the last two months
- c. Immunocompromised or severely ill
- d. Genetic disorders (e.g. Fragile X Syndrome)
- e. Chronic health conditions such as diabetes, heart disease or an eating disorder.
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Interventions
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) and receive the investigational product. Phase 1B will commence immediately following completion of Phase 1A. The total duration of the trial (Phase 1A + Phase 1B) is 16 weeks. Participants in the intervention group will receive the HMO product for a total of 16 weeks, while participants in the control group will receive a placebo for 8 weeks and the HMO product for 8 weeks. Mode of administration: oral, powder. The investigational product has a very mild taste and is a colourless and odourless and completely dissolves in liquid or semi-solid food. Dosing: two sachet/day (6g/day). Parents/guardians will be encouraged to administer one (1) sachet in the morning and one (1) sachet in the afternoon/evening. The daily dose (2 sachets/day = 6g/day) of the investigational product contains: 1) 2.5g of a proprietary mix of four HMOs, combined with 2) 20 billion CFUs of probiotics (Lactobacillus rhamnosus; Lactobacillus plantarum; Bifidobacterium animalis spp. lactis; and Bifidobacterium longum). Compliance: parents/guardian of participants will be provided with a "Participant Monitoring Sheet" to note dosing compliance which will be follow-up fortnightly by the research team (phone/email).
Locations(1)
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ACTRN12621001575820