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

This study has been completed.
Sponsor:
Collaborators:
USDA Beltsville Human Nutrition Research Center
Penn State University
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00760851
First received: September 24, 2008
Last updated: March 17, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Infections, Respiratory
Diarrhea
Other: probiotic strain Bb-12
Other: no Bb-12
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study to Investigate the Potential of Probiotics II

Resource links provided by NLM:


Further study details as provided by Georgetown University:

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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760851

Locations
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
USDA Beltsville Human Nutrition Research Center
Penn State University
Investigators
Principal Investigator: Daniel Merenstein, MD Georgetown University
  More Information

No publications provided

Responsible Party: Dr. Daniel Merenstein, M.D., Georgetown University
ClinicalTrials.gov Identifier: NCT00760851     History of Changes
Other Study ID Numbers: 2008-01852
Study First Received: September 24, 2008
Last Updated: March 17, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014