RecruitingACTRN12621001575820

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)

Sponsor

University of Queensland

Enrollment

60 participants

Start Date

May 16, 2022

Study Type

Interventional

Conditions

Dysfunctional behaviour Microbiome-gut-brain dysfunction

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

Sex: Both males and femalesMin Age: 5 YearssMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

Many children with autism spectrum disorder (ASD) experience digestive problems and behavioural difficulties, including irritability, aggression, and anxiety. Growing research suggests that the gut microbiome — the community of bacteria living in the digestive system — plays a role in brain and behaviour through what is called the gut-brain axis. This study tests whether a combination of human milk oligosaccharides (HMOs, a type of prebiotic fibre) and probiotics can improve behaviour and reduce irritability in children with ASD. The study runs in two phases: eight weeks of a blinded randomised trial (where neither parents nor researchers know who is getting the real product), followed by eight weeks where all participants receive the active supplement. Your child may be eligible if they are aged 5 to 12 years and have a confirmed diagnosis of ASD or a related condition. Children with gut diseases like inflammatory bowel disease, cow's milk allergy, or those who have recently taken antibiotics or probiotics are not eligible. The supplement comes in a form that can be mixed into food or drink, making it easy to administer.

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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 ei

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)

ACT,NSW,NT,QLD,SA,WA,VIC, Australia

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ACTRN12621001575820