NCT00653705CompletedNot Applicable
The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
University of North Carolina, Chapel Hill1 site in 1 country181 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 181
- Locations
- 1
- Primary Endpoint
- Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 48 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.)
Arms & Interventions
Probiotic
Active Comparator
Children given probiotic BB12 enriched yogurt drink.
Intervention: Yogurt drink with probiotic bacteria BB12 (Other)
Control
Placebo Comparator
Children given dairy drink.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
Time Frame: 16 weeks
Secondary Outcomes
- 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.(16 weeks)
Investigators
Tamar Ringel-Kulka, MPH
Assistant Professor, Maternal and Child Health
University of North Carolina, Chapel Hill
Study Sites (1)
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