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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05151601
Registration number
NCT05151601
Ethics application status
Date submitted
17/10/2021
Date registered
9/12/2021
Date last updated
28/06/2023
Titles & IDs
Public title
Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
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Scientific title
The Effect of a Combination of Human Milk Oligosaccharides (HMOs) and Probiotics on Behavioural Change in Children With Autism Spectrum Disorder (ASD).
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Secondary ID [1]
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2020-11-30-Auts
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
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Neurodevelopmental Disorders
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Anxiety
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Experimental
Other interventions - Placebo
Experimental: HMOs + Probiotics - Dosing: A total daily dose of 2 x sachets (6g/day)
Product Comprised of:
2.5g of a proprietary blend of human milk oligosaccharides combined with
20 billion CFUs of a mixture of Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium animalis spp. lactis, and Bifidobacterium longum.
Mode of administration: oral.
Placebo Comparator: Placebo - Dosing: A total daily dose of 2 x sachets (6g/day)u (8 weeks of phase 1A). Product: powdered maltodextrin. Mode of administration: oral.
Other interventions: Experimental
2 x sachets per day
Other interventions: Placebo
2 x sachets per day
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Behaviour change
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18)
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Primary outcome [2]
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Behaviour Change
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Phase 1A midpoint (week 4) and post-Phase 1A (week 8/9)
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Primary outcome [3]
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Behaviour Change
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and post-Phase 1A (week 8/9)
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Secondary outcome [1]
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Change in GI Symptom Severity
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Assessment method [1]
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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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Timepoint [1]
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Baseline and post-Phase 1A (week 8/9)
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Secondary outcome [2]
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Change in the Gut Microbiome
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and post-Phase 1A (week 8/9)
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Secondary outcome [3]
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Change in Anxiety Levels
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and post-Phase 1A (week 8/9)
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Secondary outcome [4]
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Change in Quality of Life
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and post-Phase 1A (week 8/9)
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Secondary outcome [5]
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Change in Stool Consistency
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Assessment method [5]
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Change in Stool consistency as measured by the Bristol Stool Chart (BSC, paediatric version)
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Timepoint [5]
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Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) .
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Secondary outcome [6]
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Change in stool short chain fatty acids levels
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Assessment method [6]
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Change in stool short chain fatty acids levels as measured using gas chromatography with flame ionisation detection (GC-FID)
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Timepoint [6]
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Baseline and post-Phase 1A (weeks 8/9)
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Secondary outcome [7]
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Change in urinary serotonin concentration
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Assessment method [7]
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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)
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Timepoint [7]
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Baseline and post-Phase 1A (weeks 8/9)
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Secondary outcome [8]
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Change in salivary cortisol levels
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Assessment method [8]
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Change to salivary cortisol levels as measured using the Elecsys® Cortisol II assay
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Timepoint [8]
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Baseline and post-Phase 1A (weeks 8/9)
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Eligibility
Key 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.
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Minimum age
5
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2023
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland, Child Health Research Centre - Brisbane
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Recruitment postcode(s) [1]
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4001 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05151601
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter SW Davies, PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05151601
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