Diarrhea, Infections, Respiratory
Conditions
Keywords
Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system
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 school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare. In this study, participants will be asked to: 1. Give their child 4 oz. of the test yogurt each day for 90 days 2. Keep a daily diary of their child's health 3. Collect 3 stool samples from their child at the start, middle, and end of the study 4. Speak with research personnel on a bi-weekly basis regarding their child's health 5. Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
Interventions
OTHERprobiotic strain Bb-12
10\^9 CFU Bb-12 per 4 oz yogurt
OTHERno Bb-12
yogurt identical to intervention yogurt, only without Bb-12 added.
Sponsors
United States Department of Agriculture (USDA)
Penn State University
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Child aged 2 to 4 years of age * Child attends daycare at least 3 days per week
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school | 90 |
Countries
United States
Outcome results
None listed