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

March 17, 2011 updated by: Georgetown University

Study to Investigate the Potential of Probiotics II

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Georgetown University Department of Family Medicine, Research Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 90
90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Penn State University
United States Department of Agriculture (USDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2011

Last Update Submitted That Met QC Criteria

March 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-01852

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhea

Clinical Trials on probiotic strain Bb-12

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe