Status:
COMPLETED
Yogurt Study in Children 2-4 Years Old Attending Daycare
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Penn State University
Conditions:
Infections, Respiratory
Diarrhea
Eligibility:
All Genders
2-4 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from schoo...
Eligibility Criteria
Inclusion
- Child aged 2 to 4 years of age
- Child attends daycare at least 3 days per week
Exclusion
- Caregiver does not speak English or Spanish
- Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
- Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
- Caregiver does not have a refrigerator to store the yogurt product at home
- Child is currently receiving breast milk
- Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose
- Child has an allergy or hypersensitivity to strawberry or red food coloring
- Child has a chronic disease
- Child has had an infection or been sick 7 days prior to starting study
- Child has had diarrhea or constipation 7 days prior to starting study
- Child has a special diet as prescribed by a medical professional
- Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study
- Child has a congenital anomaly or birth defect that requires medical care
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00760851
Start Date
September 1 2008
End Date
July 1 2010
Last Update
March 18 2011
Active Locations (1)
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1
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, United States, 20009