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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMOs + Probiotics | Experimental | Dosing: A total daily dose of 2 x sachets (6g/day) Product Comprised of:
Mode of administration: oral. |
|
| Placebo | Placebo Comparator | Dosing: A total daily dose of 2 x sachets (6g/day)u (8 weeks of phase 1A). Product: powdered maltodextrin. Mode of administration: oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Dietary Supplement | 2 x sachets per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Behaviour change | Changes in behavioural symptoms as measured by the Irritability sub-scale of the Aberrant Behavior Checklist - Community (Version 2) (I-ABC). The ABC 58-item parent-rated questionnaire and consists of five subscales, including: 1) irritability (15 items); 2) lethargy/social withdrawal (16 items); 3) stereotypic behaviour (7 items); 4) hyperactivity/noncompliance (16 items); and 5) inappropriate speech (4 items). Each item is scored as 0=never a problem, 1=slight problem, 2=moderately serious problem, or 3=severe problem. The score range is 0-174, with a higher score indicating greater severity or difficulties. | Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18) |
| Behaviour Change | Changes in behavioural symptoms as measured by the Home Situations Questionnaire - Autism Spectrum Disorder (HSQ-ASD). The HSQ-ASD is a 24-item, parent-rated measure of non compliant behaviour in children with ASD. The scale yields per-item mean scores of 0 to 9, with higher scores indicating greater noncompliance. | Baseline, Phase 1A midpoint (week 4) and post-Phase 1A (week 8/9) |
| Behaviour Change | Changes in parent/guardian targeted behaviours as measured by the Parent Targeted Symptom Visual Analogue Scale (PTSVAS). The PTSVAS tool requests parents/guardians report their top three (3) target behaviours (behaviours of concern) on a Visual Analogue Scale (VAS). The VAS is a horizontal line of 100mm in length, with each end defined as the extreme limits of the behaviour of concern ("best" to "worst"), to be measured from left to right. The parents will score the behaviour by placing a mark on the VAS at baseline and post-intervention. Each mark will be measured on the scale of 0-100mm and the change from baseline to post-intervention noted. | Baseline and post-Phase 1A (week 8/9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GI Symptom Severity | Change in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI). The 6-GSI assesses each GI symptom using a Likert scale of 0-2 (0 = nil/mild/infrequent; 1 = moderate/occasional; 2 = severe/frequent). Score range 0-12. Mild GI issues are defined as a score of under three and moderate or severe GI issues defined as a score of three or above. |
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Inclusion Criteria:
Exclusion Criteria:
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 who have 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:
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| Name | Affiliation | Role |
|---|---|---|
| Peter SW Davies, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Queensland, Child Health Research Centre | Brisbane | Queensland | 4001 | Australia |
IPD is the intellectual property of the funding industry partner.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001008 | Anxiety Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D001523 | Mental Disorders |
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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.
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| Placebo |
| Other |
2 x sachets per day |
|
| Baseline and post-Phase 1A (week 8/9) |
| Change in the Gut Microbiome | This is an explorative outcome to compare and characterise changes in gut (stool) micorbiome between treatment groups. Change or trends (diversity, bacterial species, metabolite potential) in the gut microbiome as analysed using stool shotgun metagenomic sequencing. | Baseline and post-Phase 1A (week 8/9) |
| Change in Anxiety Levels | Change in anxiety levels as measured by the Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) questionnaire. This is a 25-item tool using a Likert scale of 0-3 (0=none; 1=mild; 2=moderate; 3=severe). Score range 0-75, with higher scores indicating greater levels of anxiety. | Baseline and post-Phase 1A (week 8/9) |
| Change in Quality of Life | Quality of life (QoL) measured by the Quality of life Autism (QoLA) questionnaire. The QoLA is a 48-item questionnaire divided into 2 subsets (Part A and Part B). The QoLA utilises a 5-point scale (0-4). Possible scores range from 48-240, with higher scores equating to higher perceived QoL. | Baseline and post-Phase 1A (week 8/9) |
| Change in Stool Consistency | Change in Stool consistency as measured by the Bristol Stool Chart (BSC, paediatric version) | Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) . |
| Change in stool short chain fatty acids levels | Change in stool short chain fatty acids levels as measured using gas chromatography with flame ionisation detection (GC-FID) | Baseline and post-Phase 1A (weeks 8/9) |
| Change in urinary serotonin concentration | Change in concentrations of the urinary serotonin metabolite, 5-Hydroxyindoleacetic acid as measured using a double solvent front extraction, followed by reversed phase High Performance Liquid Chromatography (HPLC) with electrochemical detection (ECD) | Baseline and post-Phase 1A (weeks 8/9) |
| Change in salivary cortisol levels | Change to salivary cortisol levels as measured using the Elecsys® Cortisol II assay | Baseline and post-Phase 1A (weeks 8/9) |