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

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT00760851

Collaborator

United States Department of Agriculture (USDA) (U.S. Fed), Penn State University (Other)

190

Enrollment

Location

Arms

21.9

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infections, Respiratory Diarrhea	Other: probiotic strain Bb-12 Other: no Bb-12	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Study to Investigate the Potential of Probiotics II

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Bb-12 supplemented strawberry yogurt drink

Other: probiotic strain Bb-12

10^9 CFU Bb-12 per 4 oz yogurt

Other Names:

Bifidobacterium lactis 12

Placebo Comparator: 2

Regular strawberry yogurt drink with no Bb-12 added

Other: no Bb-12

yogurt identical to intervention yogurt, only without Bb-12 added.

Outcome Measures

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 [90 days]

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 [90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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