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

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ClinicalTrials.gov Identifier: NCT00653705
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : May 31, 2013
Sponsor:
Collaborator:
General Mills
Information provided by (Responsible Party):
Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill

Study Description
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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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653705


Locations
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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
Investigators
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Principal Investigator: Tamar Ringel-Kulka, MD, MPH University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tamar Ringel-Kulka, MPH, Assistant Professor, Maternal and Child Health, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00653705    
Other Study ID Numbers: 06-0901
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill:
Probiotics
Children
Child Care Center
Nutrition
Health promotion