Clinical trial NCT05151601: Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
Official title: The Effect of a Combination of Human Milk Oligosaccharides (HMOs) and Probiotics on Behavioural Change in Children With Autism Spectrum Disorder (ASD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Neurodevelopmental Disorders
Anxiety
Keywords: Gut microbiome
Behaviour
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be recruited into a two-phase project. Phase 1A: an 8-week double-blinded, placebo-controlled, randomised trial. Participants child will be randomised to one of groups 1) treatment (HMOs/Probiotic group) or 2) control group (placebo product).

Phase 1B: is an 8-week open-label trial. All children who successfully complete phase 1A will be recruited into phase 1B. All participants in phase 1B will receive the treatment product (HMOs/probiotics).

Follow up will occur at week 8 and week 17.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Behaviour change
timeFrame: Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18)
measure: Behaviour Change
timeFrame: Baseline, Phase 1A midpoint (week 4) and post-Phase 1A (week 8/9)
measure: Behaviour Change
timeFrame: Baseline and post-Phase 1A (week 8/9)
Secondary outcomes:
measure: Change in GI Symptom Severity
timeFrame: Baseline and post-Phase 1A (week 8/9)
measure: Change in the Gut Microbiome
timeFrame: Baseline and post-Phase 1A (week 8/9)
measure: Change in Anxiety Levels
timeFrame: Baseline and post-Phase 1A (week 8/9)
measure: Change in Quality of Life
timeFrame: Baseline and post-Phase 1A (week 8/9)
measure: Change in Stool Consistency
timeFrame: Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) .
measure: Change in stool short chain fatty acids levels
timeFrame: Baseline and post-Phase 1A (weeks 8/9)
measure: Change in urinary serotonin concentration
timeFrame: Baseline and post-Phase 1A (weeks 8/9)
measure: Change in salivary cortisol levels
timeFrame: Baseline and post-Phase 1A (weeks 8/9)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: University of Queensland, Child Health Research Centre
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Peter SW Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References: