The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
|ClinicalTrials.gov Identifier: NCT00653705|
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Children's Health and Growth Childcare Absenteeism||Other: Yogurt drink with probiotic bacteria BB12 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2009|
Active Comparator: Probiotic
Children given probiotic BB12 enriched yogurt drink.
Other: Yogurt drink with probiotic bacteria BB12
Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
Placebo Comparator: Control
Children given dairy drink.
Vanilla flavored dairy drink. One bottle a day for 16 weeks.
- Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism [ Time Frame: 16 weeks ]
- 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. [ Time Frame: 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653705
|United States, North Carolina|
|University of North Carolina at Chapel Hill, School of Public Health|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Tamar Ringel-Kulka, MD, MPH||University of North Carolina, Chapel Hill|