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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

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 7, 2008
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
Official Title  ICMJE The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Children's Health and Growth
  • Childcare Absenteeism
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Ringel-Kulka T, Kotch JB, Jensen ET, Savage E, Weber DJ. Randomized, double-blind, placebo-controlled study of synbiotic yogurt effect on the health of children. J Pediatr. 2015 Jun;166(6):1475-81.e1-3. doi: 10.1016/j.jpeds.2015.02.038. Epub 2015 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
181
Original Actual Enrollment  ICMJE
 (submitted: April 4, 2008)
204
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653705
Other Study ID Numbers  ICMJE 06-0901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE General Mills
Investigators  ICMJE
Principal Investigator: Tamar Ringel-Kulka, MD, MPH University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2013

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