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Trial registered on ANZCTR


Registration number
ACTRN12622000153718
Ethics application status
Approved
Date submitted
4/01/2022
Date registered
31/01/2022
Date last updated
20/03/2023
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of probiotics on the immune system and development of young children
Scientific title
The impact of probiotics on the absence from childcare due to illness and physical and psychological developmental milestones of children in Australian childcare centres: A double-blinded randomised controlled trial
Secondary ID [1] 305848 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune system 324827 0
Physical Development 324828 0
Psychological development 324956 0
Condition category
Condition code
Inflammatory and Immune System 322265 322265 0 0
Normal development and function of the immune system
Mental Health 322385 322385 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biome Daily Kids™ Probiotic

1 sachet per day for a period of 6 months.

The product contains following:

Lactobacillus plantarum 6595 (ATCC 53103) 3 billion active fluorescent units (AFU)
Lactobacillus rhamnosus GG (ATCC 53103) 2 billion AFU
Bifidobacterium animalis subsp. lactis BS01 (LMG P-21384) 2 billion AFU
Lactobacillus casei LC03 (DSM 27537) 1 billion AFU
Bifidobacterium breve BR03 (DSM 16604) 2 billion AFU
Total 10 billion AFU

Route of administration: Dissolve in water or milk or mix with yogurt.

Strategies to monitor and support adherence: Weekly three minutes surveys - which will include a reminder and where parents can report supplementation missed day/s.

Intervention code [1] 322538 0
Prevention
Comparator / control treatment
Placebo is also prepared by Biome Australia Ltd.

The placebo consists of identical packaging to the active material containing the same carrier formulation but without the active probiotic strains.
1 sachet per day for a period of 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 330024 0
Incidence of common infections such as gastrointestinal tract infections (GITIs) and respiratory tract infections (RITIs).
Method of assessment: Parents will provide relevant information in a short weekly survey designed specifically for this study.
Timepoint [1] 330024 0
Weekly for 6 months after the initiation of probiotic supplementation.
Primary timepoint - 6 months post-intervention commencement.
Primary outcome [2] 330025 0
Absence from childcare centre due to infection.
Method of assessment: Parents will provide relevant information in a short weekly survey designed specifically for this study.
Timepoint [2] 330025 0
Weekly for 6 months after the initiation of probiotic supplementation.
Primary timepoint - 6 months post-intervention commencement.
Primary outcome [3] 330173 0
Change in psychological development assessed using the Ages & Stages Questionnaires, Third Edition (ASQ-3) and Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2).
Timepoint [3] 330173 0
Pre-intervention & Post-intervention (6 months post-intervention commencement).
Secondary outcome [1] 404642 0
Change in the physical development (composed of motor function, weight, height and BMI) of children. Motor function will be assessed by Ages & Stages Questionnaires, Third Edition (ASQ-3), whereas weight and height will be provided by parents in the pre-intervention and post-intervention study questionnaires. BMI will be calculated using the values provided by parents for each child.
Timepoint [1] 404642 0
Pre-intervention & Post-intervention (6 months post-intervention commencement).
Secondary outcome [2] 404643 0
Change in the duration of symptoms of common infections (GITIs, RTIs, etc).
Method of assessment: Parents will provide relevant information in a short weekly survey designed specifically for this study.
Timepoint [2] 404643 0
Weekly for 6 months after the initiation of probiotic supplementation.
Secondary outcome [3] 405131 0
Change in the use of prescribed antibiotics and/or other medications.
Method of assessment: Parents will provide relevant information in a short weekly survey designed specifically for this study.
Timepoint [3] 405131 0
Weekly for 6 months after the initiation of probiotic supplementation.
Secondary outcome [4] 405132 0
Changes in mood as reported by the parents through open-ended questions in the post-intervention study questionnaire designed specifically for this study.
Timepoint [4] 405132 0
Post-intervention (6 months post-intervention commencement).
Secondary outcome [5] 405136 0
Changes in behavior as reported by the parents through open-ended questions in the post-intervention study questionnaire designed specifically for this study.
Timepoint [5] 405136 0
Post-intervention (6 months post-intervention commencement).

Eligibility
Key inclusion criteria
-Children over the age of two years
-Children attending childcare centres for a minimum period of 15 hours per week
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Children receiving probiotic and/or prebiotic products at the time of enrolment and parents not agreeing to stop all other sources of probiotic and/or prebiotic for the duration of the study.
-Children receiving any medication that can interact with the probiotic supplement or impact the immune system or cognitive function
-Children who had any severe chronic illness, including but not limited to neoplasm, immune deficiency and chronic diarrhea

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done by central randomization using computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using SPSS
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/02/2022
Actual
7/09/2022
Date of last participant enrolment
Anticipated
15/05/2022
Actual
10/02/2023
Date of last data collection
Anticipated
15/10/2023
Actual
Sample size
Target
125
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310205 0
Commercial sector/Industry
Name [1] 310205 0
Biome Australia Trading Pty Ltd
Country [1] 310205 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Dr, Mount Helen VIC 3350
Country
Australia
Secondary sponsor category [1] 311293 0
None
Name [1] 311293 0
Address [1] 311293 0
Country [1] 311293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309885 0
Federation University Human research ethics committee
Ethics committee address [1] 309885 0
Ethics committee country [1] 309885 0
Australia
Date submitted for ethics approval [1] 309885 0
10/11/2021
Approval date [1] 309885 0
21/02/2022
Ethics approval number [1] 309885 0
A21-163

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

Contacts
Principal investigator
Name 115726 0
Dr Blake Peck
Address 115726 0
Federation University, University Dr, Mount Helen VIC 3350
Country 115726 0
Australia
Phone 115726 0
+61035327 9097
Fax 115726 0
Email 115726 0
b.peck@federation.edu.au
Contact person for public queries
Name 115727 0
Haris Ahmad
Address 115727 0
Federation University, University Dr, Mount Helen VIC 3350
Country 115727 0
Australia
Phone 115727 0
+61452283357
Fax 115727 0
Email 115727 0
h.ahmad@federation.edu.au
Contact person for scientific queries
Name 115728 0
Haris Ahmad
Address 115728 0
Federation University, University Dr, Mount Helen VIC 3350
Country 115728 0
Australia
Phone 115728 0
+61452283357
Fax 115728 0
Email 115728 0
h.ahmad@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethical considerations.


What supporting documents are/will be available?

No Supporting Document Provided



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.