Yogurt Study in Children 2-4 Years Old Attending Daycare - Full Text View

Sponsors and Collaborators:	Georgetown University United States Department of Agriculture Penn State University
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00760851

Purpose

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

Condition	Intervention	Phase
Infections, Respiratory Diarrhea	Other: probiotic strain Bb-12 Other: no Bb-12	Phase III

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study to Investigate the Potential of Probiotics II

Further study details as provided by Georgetown University:

Primary Outcome Measures:

To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school [ Time Frame: 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	190
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bb-12 supplemented strawberry yogurt drink	Other: probiotic strain Bb-12 10^9 CFU Bb-12 per 4 oz yogurt
2: Placebo Comparator Regular strawberry yogurt drink with no Bb-12 added	Other: no Bb-12 yogurt identical to intervention yogurt, only without Bb-12 added.

Eligibility

Ages Eligible for Study:	2 Years to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760851

Contacts

Contact: Amy Guimaraes, M.S.	202-687-5193	alg38@georgetown.edu
Contact: Haewon Park, MPH	202-687-0426	hp47@georgetown.edu

Locations

United States, District of Columbia
Georgetown University Department of Family Medicine, Research Division	Recruiting
Washington, District of Columbia, United States, 20009
Contact: Amy Guimaraes, MS alg38@georgetown.edu
Contact: Daniel Merenstein, MD 202-687-2745 djm23@georgetown.edu

Sponsors and Collaborators

Georgetown University

United States Department of Agriculture

Penn State University

Investigators

Principal Investigator:

Daniel Merenstein, MD

Georgetown University

More Information

Responsible Party:	Georgetown University ( Dr. Daniel Merenstein, M.D. )
Study ID Numbers:	2008-01852
Study First Received:	September 24, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00760851
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Probiotics
Child, preschool
Child Day Care Centers
Health
Immune system

Study placed in the following topic categories:

Diarrhea
Respiratory Tract Diseases
Respiratory Tract Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 14, 2009