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

This study has been completed.
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00653705
First received: April 1, 2008
Last updated: May 30, 2013
Last verified: May 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 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. Exploratory biomarker outcomes in stool. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Chapel Hill
General Mills Inc.
Investigators
Principal Investigator: Tamar Ringel-Kulka, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Tamar Ringel-Kulka, MPH, Assistant Professor, Maternal and Child Health, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00653705     History of Changes
Other Study ID Numbers: 06-0901
Study First Received: April 1, 2008
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Probiotics
Children
Child Care Center
Nutrition
Health promotion

ClinicalTrials.gov processed this record on August 26, 2014