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Yogurt Study in Children 2-4 Years Old Attending Daycare (SIPPY II)

Primary Purpose

Infections, Respiratory, Diarrhea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
probiotic strain Bb-12
no Bb-12
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Respiratory focused on measuring Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Georgetown University Department of Family Medicine, Research Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Bb-12 supplemented strawberry yogurt drink

Regular strawberry yogurt drink with no Bb-12 added

Outcomes

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

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

Full Information

First Posted
September 24, 2008
Last Updated
March 17, 2011
Sponsor
Georgetown University
Collaborators
United States Department of Agriculture (USDA), Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT00760851
Brief Title
Yogurt Study in Children 2-4 Years Old Attending Daycare
Acronym
SIPPY II
Official Title
Study to Investigate the Potential of Probiotics II
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Georgetown University
Collaborators
United States Department of Agriculture (USDA), Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory, Diarrhea
Keywords
Probiotics, Child, preschool, Child Day Care Centers, Health, Immune system

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bb-12 supplemented strawberry yogurt drink
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Regular strawberry yogurt drink with no Bb-12 added
Intervention Type
Other
Intervention Name(s)
probiotic strain Bb-12
Other Intervention Name(s)
Bifidobacterium lactis 12
Intervention Description
10^9 CFU Bb-12 per 4 oz yogurt
Intervention Type
Other
Intervention Name(s)
no Bb-12
Intervention Description
yogurt identical to intervention yogurt, only without Bb-12 added.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Merenstein, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Department of Family Medicine, Research Division
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States

12. IPD Sharing Statement

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Yogurt Study in Children 2-4 Years Old Attending Daycare

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