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”

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.

Intervention(s) in this Clinical Trial

• Other: Yogurt drink with probiotic bacteria BB12
  • Probiotic yogurt dairy drink with Bifidiobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
• Other: Placebo
  • Vanilla flavored dairy drink. One bottle a day for 16 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Probiotic
  • Children given probiotic BB12 enriched yogurt drink.
• Placebo Comparator: Control
  • Children given dairy drink.

Primary Measures

• Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary 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.
  • Time Frame: 16 weeks
    Safety Issue?: No

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.)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Months

Maximum Age for this Clinical Trial: 48 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of North Carolina Other

Overall Clinical Trial Officials and Contacts

Tamar Ringel-Kulka, MD, MPH Principal Investigator University of North Carolina, Chapel Hill  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653705

Study ID Number: 06-0901

ClinicalTrials.gov Identifier: NCT00653705

Health Authority: United States: Institutional Review Board