The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism - Full Text View

Sponsors and Collaborators:	University of North Carolina General Mills Inc.
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00653705

Purpose

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.

Condition	Intervention
Children's Health and Growth Childcare Absenteeism	Other: Yogurt drink with probiotic bacteria BB12 Other: Placebo

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	204
Study Start Date:	January 2007
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Probiotic: Active Comparator Children given probiotic BB12 enriched yogurt drink.	Other: Yogurt drink with probiotic bacteria BB12 Probiotic yogurt dairy drink with Bifidiobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
Control: Placebo Comparator Children given dairy drink.	Other: Placebo Vanilla flavored dairy drink. One bottle a day for 16 weeks.

Eligibility

Ages Eligible for Study:	12 Months to 48 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653705

Locations

United States, North Carolina
University of North Carolina at Chapel Hill, School of Public Health
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina

General Mills Inc.

Investigators

Principal Investigator:

Tamar Ringel-Kulka, MD, MPH

The University of North Carolina, Chapel Hill

More Information

Responsible Party:	University of North Carolina School of Public Health ( Tamar Ringel-Kulka, MD, MPH )
Study ID Numbers:	06-0901
Study First Received:	April 1, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00653705
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Probiotics
Children
Child Care Center
Nutrition
Health promotion

ClinicalTrials.gov processed this record on January 16, 2009