None listed
Conditions
Brief summary
This study will investigate the effect of an oral probiotic (manufactured by BLIS technologies) on preventing very common infectious problems during early infancy, particularly ear infections (otitis media), upper respiratory tract infections and reducing dental caries. The probiotic is known to reduce the bacteria that cause these infections and this study will examine the potential of this probiotic to prevent them when taken daily by infants from 6 months to 24 months of age.
Interventions
A probiotic powder containing Streptococcus salivarius K12 (at least 1.25 billion CFU/dose), isomalt, maltodextrin and natural flavour (strawberry) will be taken daily by participants in the active group from the age of 6 months to 24 months of age.
Parents/caregivers will provide a 1.25 cubic centimetre (CC ~ 1/4 teaspoon) spoonful of the powder to infants orally preferably after food by one of the following methods; mixing on a clean spoon with a small amount of water, breast milk or for
A probiotic powder containing Streptococcus salivarius K12 (at least 1.25 billion CFU/dose), isomalt, maltodextrin and natural flavour (strawberry) will be taken daily by participants in the active group from the age of 6 months to 24 months of age. Parents/caregivers will provide a 1.25 cubic centimetre (CC ~ 1/4 teaspoon) spoonful of the powder to infants orally preferably after food by one of the following methods; mixing on a clean spoon with a small amount of water, breast milk or formula and administered to the child's mouth and gums by the parents, using either a clean finger or provided silicon finger brush to rub the paste on. Or emptied into a provided silicon mesh infant feeder (also known as a teething feeder). Or mixed with cooled food (when children start to receive solid food). The powder will be stored in opaque plastic containers which will be weighed before given to participants and when returned, as a measure of compliance.
Sponsors
Julian Crane
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
Infant must be enrolled in a medical practice, planning to live in the Hutt Valley, Wellington or Christchurch regions for the duration of the study,
Exclusion criteria
Infants with serious medical conditions such as congenital heart conditions, severe immunodeficiency, families who plan to permanently move from the Wellington/Christchurch regions during the 18 month study period. Infants already receiving regular BLIS probiotics or a parent planning to give them to their child, children with a severe dairy allergy.
Outcome results
None listed