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

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

Tracking Information

• First Submitted Date: April 1, 2008
• First Posted Date: April 7, 2008
• Last Update Posted Date: May 31, 2013
• Study Start Date: January 2007
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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 (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: The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Children's Health and Growth
• Childcare Absenteeism

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2013): 181
• Original Actual Enrollment (submitted: April 4, 2008): 204
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months to 48 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00653705
• Other Study ID Numbers: 06-0901
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tamar Ringel-Kulka, MPH, University of North Carolina, Chapel Hill
• Study Sponsor: University of North Carolina, Chapel Hill
• Collaborators: General Mills

Investigators

• 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