Healthy
Conditions
Keywords
Probiotic, Lactobacillus, NCFM, Bifidobacterium, Healthy children
Brief summary
The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.
Interventions
DIETARY_SUPPLEMENTPlacebo
Inert excipient
DIETARY_SUPPLEMENTLactobacillus acidophilus NCFM
1e10 CFU/day
DIETARY_SUPPLEMENTCombination of Lactobacillus acidophilus and Bifidobacterium lactis
1x10e10 CFU/day
Sponsors
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 3-5 years of normal nutritional status and health
Exclusion criteria
* Contraindications to dairy products (lactose intolerance or cow's milk allergy) * Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease * Chronic cough from recurring respiratory distress-related diseases * Hirschsprung's disease * Cystic fibrosis * Other metabolic, neurological, or anatomic alteration that predisposes participation * Intake of probiotics within the last 3 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the flu-like symptoms and other symptoms of illness of preschool-age children in day care centers. | Daily for six months |
Secondary
| Measure | Time frame |
|---|---|
| To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness. | Six months |
Countries
China
Outcome results
None listed