Status:
COMPLETED
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
General Mills
Conditions:
Children's Health and Growth
Childcare Absenteeism
Eligibility:
All Genders
12-48 years
Phase:
NA
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 car...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00653705
Start Date
January 1 2007
End Date
April 1 2009
Last Update
May 31 2013
Active Locations (1)
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1
University of North Carolina at Chapel Hill, School of Public Health
Chapel Hill, North Carolina, United States, 27599