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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760851
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : March 18, 2011
United States Department of Agriculture (USDA)
Penn State University
Information provided by:
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

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2010

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 Name: 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760851

United States, District of Columbia
Georgetown University Department of Family Medicine, Research Division
Washington, District of Columbia, United States, 20009
Sponsors and Collaborators
Georgetown University
United States Department of Agriculture (USDA)
Penn State University
Principal Investigator: Daniel Merenstein, MD Georgetown University

Responsible Party: Dr. Daniel Merenstein, M.D., Georgetown University Identifier: NCT00760851     History of Changes
Other Study ID Numbers: 2008-01852
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: February 2011

Keywords provided by Georgetown University:
Child, preschool
Child Day Care Centers
Immune system

Additional relevant MeSH terms:
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Respiratory Tract Diseases