Clinical trial NCT00760851: Yogurt Study in Children 2-4 Years Old Attending Daycare
Official title: Study to Investigate the Potential of Probiotics II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Respiratory
Diarrhea
Keywords: Probiotics
Child, preschool
Child Day Care Centers
Health
Immune system
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: Penn State University
First posted: 2008-09-26
Enrollment: 190
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
timeFrame: 90 days
Secondary outcomes:
measure: Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school
timeFrame: 90
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Department of Family Medicine, Research Division
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Daniel Merenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: