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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05151601




Registration number
NCT05151601
Ethics application status
Date submitted
17/10/2021
Date registered
9/12/2021

Titles & IDs
Public title
Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
Scientific title
The Effect of a Combination of Human Milk Oligosaccharides (HMOs) and Probiotics on Behavioural Change in Children With Autism Spectrum Disorder (ASD).
Secondary ID [1] 0 0
2020-11-30-Auts
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Neurodevelopmental Disorders 0 0
Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Experimental
Other interventions - Placebo

Experimental: HMOs + Probiotics - Dosing: A total daily dose of 2 x sachets (6g/day)

Product Comprised of:

1. 2.5g of a proprietary blend of human milk oligosaccharides combined with
2. 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.


Treatment: Other: Experimental
2 x sachets per day

Other interventions: Placebo
2 x sachets per day
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Behaviour change
Timepoint [1] 0 0
Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18)
Primary outcome [2] 0 0
Behaviour Change
Timepoint [2] 0 0
Baseline, Phase 1A midpoint (week 4) and post-Phase 1A (week 8/9)
Primary outcome [3] 0 0
Behaviour Change
Timepoint [3] 0 0
Baseline and post-Phase 1A (week 8/9)
Secondary outcome [1] 0 0
Change in GI Symptom Severity
Timepoint [1] 0 0
Baseline and post-Phase 1A (week 8/9)
Secondary outcome [2] 0 0
Change in the Gut Microbiome
Timepoint [2] 0 0
Baseline and post-Phase 1A (week 8/9)
Secondary outcome [3] 0 0
Change in Anxiety Levels
Timepoint [3] 0 0
Baseline and post-Phase 1A (week 8/9)
Secondary outcome [4] 0 0
Change in Quality of Life
Timepoint [4] 0 0
Baseline and post-Phase 1A (week 8/9)
Secondary outcome [5] 0 0
Change in Stool Consistency
Timepoint [5] 0 0
Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) .
Secondary outcome [6] 0 0
Change in stool short chain fatty acids levels
Timepoint [6] 0 0
Baseline and post-Phase 1A (weeks 8/9)
Secondary outcome [7] 0 0
Change in urinary serotonin concentration
Timepoint [7] 0 0
Baseline and post-Phase 1A (weeks 8/9)
Secondary outcome [8] 0 0
Change in salivary cortisol levels
Timepoint [8] 0 0
Baseline and post-Phase 1A (weeks 8/9)

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.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland, Child Health Research Centre - Brisbane
Recruitment postcode(s) [1] 0 0
4001 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Peter SW Davies, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is the intellectual property of the funding industry partner.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05151601