None listed
Conditions
Brief summary
The aim of this study is to examine the influence of probiotic use on absenteeism due to illnesses such as gastrointestinal tract infections (GITIs), respiratory tract infections (RTIs), while also examining the physical and psychological development among children aged 2-5-years attending childcare centres in Victoria, Australia. The study is using Biome Daily kids as a probiotic intervention and placebo prepared in similar packaging by Biome Australia Trading Ltd. The study assumes that probiotic use will improve the immune system of the children and will support them to reach their optimum development.
Interventions
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
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.
Sponsors
Federation University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
-Children over the age of two years -Children attending childcare centres for a minimum period of 15 hours per week
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
Outcome results
None listed