Yogurt Study in Children 2-4 Years Old Attending Daycare

Study Overview
=================
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: Give their child 4 oz. of the test yogurt each day for 90 days Keep a daily diary of their child's health Collect 3 stool samples from their child at the start, middle, and end of the study Speak with research personnel on a bi-weekly basis regarding their child's health Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study

Official Title
-----------------
Study to Investigate the Potential of Probiotics II

Conditions
-----------------
Infections, Respiratory, Diarrhea

Intervention / Treatment
-----------------
* Other: probiotic strain Bb-12
* Other: no Bb-12


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bb-12 supplemented strawberry yogurt drink | Other: probiotic strain Bb-12<br>* 10^9 CFU Bb-12 per 4 oz yogurt<br>* Other names: Bifidobacterium lactis 12;|
| Placebo Comparator: 2<br>Regular strawberry yogurt drink with no Bb-12 added | Other: no Bb-12<br>* yogurt identical to intervention yogurt, only without Bb-12 added.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system