Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000615189
Ethics application status
Approved
Date submitted
12/04/2019
Date registered
24/04/2019
Date last updated
17/02/2021
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prebiotic supplement use, the gut microbiome and behaviour change in children with autism spectrum disorder (ASD).
Scientific title
Prebiotic supplement use, the gut microbiome and behaviour change in children with autism spectrum disorder (ASD).
Secondary ID [1] 297969 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mental health 312375 0
Condition category
Condition code
Mental Health 310932 310932 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a 6-week double blind RCT in which the intervention group (25 children with a clinical diagnosis of ASD, aged 4 to 10 years) will be given a daily dose of 2.4g of prebiotic galacto-oligosaccharides (ßGOS) divided into 4 doses of 0.6g. Each dose is contained in a capsule which should be opened and the powder mixed into 100mls of fluid / drink. Compliance will be measured by counting returned capsules on completion of the intervention, and by a supplement diary which asks a tick for each dose administered. The supplement is to be given under supervision of the parent / carer.
A parent or carer of the child participant will attend 2 research visits, the first on day 1 (baseline) and the second on day 43 (completion) of the intervention. These visits will last 1 hour. During these visits, completed questionnaires and clinical samples will be collected (see attached protocol), and standardised dietary advice will be given by one paediatric dietitian (JP), focusing on promoting positive mealtime environments, reducing stress around mealtimes and focusing on small steps involving sensory acceptance of foods.
Intervention code [1] 314190 0
Treatment: Other
Comparator / control treatment
Placebo, maltodextrin D28 (Manildra, dextrin)
2.4g of maltodextrin 28 will be given daily over 6 weeks, with dose divided into 4 x 0.6g.
A parent or carer of the child participant will attend 2 research visits where standardised dietary advice by one paediatric dietitian (JP) will be given, focusing on promoting positive mealtime environments.
Control group
Placebo

Outcomes
Primary outcome [1] 319750 0
Change in quality of life of parents and family as measured by change in quality of life scores using and autism specific QoL questionnaire (QoLA)
Timepoint [1] 319750 0
Timepoint 1: Baseline (day 0)
Timepoint 2: Completion (day 42)
Secondary outcome [1] 369404 0
Change in mealtime behaviours in participants as measured by a change in scores on the brief autism mealtime behaviour inventory (BAMBI).
Timepoint [1] 369404 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [2] 369405 0
Change in social interactions in participants using the social responsiveness (SRS-2)
Timepoint [2] 369405 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [3] 369406 0
Change in sleep onset latency (minutes) in participants, measured by a 7-day sleep diary and 7-day wearing of accelerometer.
Timepoint [3] 369406 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [4] 369407 0
Change in stool frequency in participants using the Bristol Stool Form Chart (BSFC)
Timepoint [4] 369407 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [5] 369408 0
Change in GI symptoms using an adapted Gastrointestinal Severity Index (6-GSI) questionnaire.
Timepoint [5] 369408 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [6] 369410 0
Change in basal cortisol levels of participants using ELISA assays of salivary cortisol.
Timepoint [6] 369410 0
Timepoint 1: Baseline
At 10 and 30 minutes after waking (CAR), and at 3 -4pm and before bed. 4 timepoints to asses diurnal slope.
Timepoint 2: Completion
At 10 and 30 minutes after waking (CAR), and at 3 - 4pm and before bed. 4 timepoints to asses diurnal slope.
Secondary outcome [7] 369411 0
Change in microbiota profile using 16SrRNA sequencing of bacterial DNA from stool samples
Timepoint [7] 369411 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [8] 369412 0
Change in dietary intake measured by a 3-day food record.
Timepoint [8] 369412 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [9] 369534 0
Change in duration of uninterrupted sleep (minutes) in participants measured by a 7-day sleep diary and accelerometer.
Timepoint [9] 369534 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [10] 369535 0
Change in number of night-time waking's in participants measured by a 7-day sleep diary and accelerometer.
Timepoint [10] 369535 0
Timepoint 1: Baseline
Timepoint 2: Completion
Secondary outcome [11] 369630 0
Change in stool consistency in child participants using the Bristol Stool Form Chart (BSFC).
Timepoint [11] 369630 0
Timepoint 1: Baseline
Timepoint 2: Completion

Eligibility
Key inclusion criteria
a formal diagnosis of ASD (presentation of medical letter of diagnosis),
child participants aged between 4 and 10 years
parent / carer english speaking
naïve to dietary intervention involving prebiotic supplementation
parents of participants must agree to all aspects of the protocol.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no recent use (within last 3 months) of antibiotics
no recently commenced prebiotics (within the past month)
no recently commenced probiotics (within the past month)
no new medications (or dose change) for anxiety, sleep or behaviour (within the past 2 months)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Both control and intervention group will receive standard dietetic counselling on 2 occassions throughout the study. This will be carried out by the same dietitian to ensure identical information given to both groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial is designed as a pilot study which will serve to inform the design of larger studies in the future. Recruitment will occur on a rolling basis and will endeavour to recruit enough participants to have 50 participants at completion. The primary analysis will address Intention to treat (ITT) followed by secondary analysis of the Per Protocol (PP) group. Basic descriptive statistics will be used to compare control and treatment groups allowing for baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2019
Actual
17/05/2019
Date of last participant enrolment
Anticipated
30/09/2019
Actual
30/03/2020
Date of last data collection
Anticipated
11/11/2019
Actual
30/05/2020
Sample size
Target
50
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302491 0
University
Name [1] 302491 0
Queensland University of Technology
Country [1] 302491 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Corner of Musk and Victoria Park Road, Kelvin Grove, 4059, QLD
Country
Australia
Secondary sponsor category [1] 302393 0
Individual
Name [1] 302393 0
Jacqui Palmer (PhD Candidate)
Address [1] 302393 0
Queensland University of Technology (QUT)
School of Exercise and Nutrition Sciences
O block, A wing
Kelvin Grove Road, Queensland 4059
Country [1] 302393 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303149 0
Queensland University of Technology Human Research Ethics Comittee
Ethics committee address [1] 303149 0
Ethics committee country [1] 303149 0
Australia
Date submitted for ethics approval [1] 303149 0
29/07/2018
Approval date [1] 303149 0
04/11/2018
Ethics approval number [1] 303149 0
1800000774

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92646 0
Ms Jacqui Palmer
Address 92646 0
QUT, Kelvin Grove Campus
Queensland University of Technology (QUT)
School of Nutrition and Exercise Sciences
O block, A wing
Kelvin Grove 4059
Queensland
Country 92646 0
Australia
Phone 92646 0
+61 470317447
Fax 92646 0
Email 92646 0
[email protected]
Contact person for public queries
Name 92647 0
Jacqui Palmer
Address 92647 0
QUT, Kelvin Grove Campus
Queensland University of Technology (QUT)
School of Nutrition and Exercise Sciences
O block, A wing
Kelvin Grove, 4059
Queensland
Country 92647 0
Australia
Phone 92647 0
+61 470317447
Fax 92647 0
Email 92647 0
[email protected]
Contact person for scientific queries
Name 92648 0
Jacqui Palmer
Address 92648 0
QUT, Kelvin Grove Campus
Queensland University of Technology (QUT)
School of Nutrition and Exercise Sciences
O block, A wing
Kelvin Grove, 4059
Queensland
Country 92648 0
Australia
Phone 92648 0
+61 470317447
Fax 92648 0
Email 92648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A summary of results will be provided to participants but no individual data will be shared.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.