Yogurt Study in Children 2-4 Years Old Attending Daycare | NCT00760851

Studies
Yogurt Study in Children 2-4 Years Old Attending Daycare

NCT00760851

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Mar 18, 2011Estimated

Enrollment

190Estimated

Phase

Phase 3

Conditions

Infections, Respiratory
Diarrhea

Interventions

probiotic strain Bb-12
no Bb-12

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2011

Last Update Posted Date

Mar 18, 2011Estimated

Name	Class
United States Department of Agriculture (USDA)	FED
Penn State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Bb-12 supplemented strawberry yogurt drink	Other: probiotic strain Bb-12
2	Placebo Comparator	Regular strawberry yogurt drink with no Bb-12 added	Other: no Bb-12

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotic strain Bb-12	Other	10^9 CFU Bb-12 per 4 oz yogurt	1	Bifidobacterium lactis 12

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Merenstein, MD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Department of Family Medicine, Research Division		Washington D.C.	District of Columbia	20009	United States

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D003967	Diarrhea

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

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Browse Branches

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