Childcare Absenteeism, Children's Health and Growth
Conditions
Keywords
Probiotics, Children, Child Care Center, Nutrition, Health promotion
Brief summary
The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.
Interventions
OTHERYogurt drink with probiotic bacteria BB12
Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
OTHERPlacebo
Vanilla flavored dairy drink. One bottle a day for 16 weeks.
Sponsors
General Mills
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* An informed consent has been signed by the parents. * The child is at least one year old and has not had his 4th birthday at the beginning of the study * The child is healthy. * The child attends child care center at least 5 days a week, \> 4 hours per day.
Exclusion criteria
* Was born preterm. * Had a birth weight \<2,500 g. * Has congenital anomalies. * Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery. * Has chronic disease or malignancy. * Has a serious, unstable medical condition. * Is Failure to Thrive (FTT) (\<5th percentile of ideal body weight). * Has an allergy or atopic disease. * Has an allergy or intolerance to milk/dairy products. * Has an established diagnosis of lactase deficiency. * Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment). * Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Health care utilization and illness related costs as measured by number of physician visits, ER visits, hospitalizations, and antibiotics use. Also, child growth and quality of life. Exploratory biomarker outcomes in stool. | 16 weeks |
Countries
United States
Outcome results
None listed