Yogurt Study in Children 2-4 Years Old Attending Daycare

Diarrhea Clinical Trial

— SIPPY II  

Official title:

Study to Investigate the Potential of Probiotics II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760851
• Other study ID #: 2008-01852
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2008
• Last updated: March 17, 2011
• Start date: September 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Infections, Respiratory
• Respiratory Tract Infections

Intervention

Other:
• probiotic strain Bb-12
10^9 CFU Bb-12 per 4 oz yogurt
• no Bb-12
yogurt identical to intervention yogurt, only without Bb-12 added.

Locations

Country	Name	City	State
United States	Georgetown University Department of Family Medicine, Research Division	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	Penn State University, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school		90	No