The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism

Study Overview
=================
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.

Official Title
-----------------
The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism

Conditions
-----------------
Children's Health and Growth, Childcare Absenteeism

Intervention / Treatment
-----------------
* Other: Yogurt drink with probiotic bacteria BB12
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.)

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 48 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Children given probiotic BB12 enriched yogurt drink. | Other: Yogurt drink with probiotic bacteria BB12<br>* Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.<br>|
| Placebo Comparator: Control<br>Children given dairy drink. | Other: Placebo<br>* Vanilla flavored dairy drink. One bottle a day for 16 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Children, Child Care Center, Nutrition, Health promotion