Yogurt Study in Children 2-4 Years Old Attending Daycare

Phase 3

Completed

• Conditions: Infections, Respiratory; Diarrhea
• Interventions: Other: probiotic strain Bb-12; Other: no Bb-12

• Registration Number: NCT00760851
• Lead Sponsor: Georgetown University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2009-07
• Study Completion: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	probiotic strain Bb-12	Bb-12 supplemented strawberry yogurt drink
2	no Bb-12	Regular strawberry yogurt drink with no Bb-12 added

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school	90

Trial Locations

Locations (1)

Georgetown University Department of Family Medicine, Research Division; 🇺🇸 Washington, District of Columbia, United States