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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

April 1, 2008
May 30, 2013
January 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00653705 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Children's Health and Growth
  • Childcare Absenteeism
  • Other: Yogurt drink with probiotic bacteria BB12
    Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
  • Other: Placebo
    Vanilla flavored dairy drink. One bottle a day for 16 weeks.
  • Active Comparator: Probiotic
    Children given probiotic BB12 enriched yogurt drink.
    Intervention: Other: Yogurt drink with probiotic bacteria BB12
  • Placebo Comparator: Control
    Children given dairy drink.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
April 2009
April 2008   (final data collection date for primary outcome measure)

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.)
Both
12 Months to 48 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653705
06-0901
No
Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
General Mills Inc.
Principal Investigator: Tamar Ringel-Kulka, MD, MPH University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP