Clinical trial NCT00653705: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children's Health and Growth
Childcare Absenteeism
Keywords: Probiotics
Children
Child Care Center
Nutrition
Health promotion
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2008-04-07
Enrollment: 181
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.)

Primary outcomes:
measure: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
timeFrame: 16 weeks
Secondary outcomes:
measure: 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.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, School of Public Health
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Tamar Ringel-Kulka, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.