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

September 24, 2008
March 17, 2011
September 2008
July 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00760851 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Yogurt Study in Children 2-4 Years Old Attending Daycare
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infections, Respiratory
  • Diarrhea
  • Other: probiotic strain Bb-12
    10^9 CFU Bb-12 per 4 oz yogurt
    Other Name: Bifidobacterium lactis 12
  • Other: no Bb-12
    yogurt identical to intervention yogurt, only without Bb-12 added.
  • Experimental: 1
    Bb-12 supplemented strawberry yogurt drink
    Intervention: Other: probiotic strain Bb-12
  • Placebo Comparator: 2
    Regular strawberry yogurt drink with no Bb-12 added
    Intervention: Other: no Bb-12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
July 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760851
2008-01852
Yes
Dr. Daniel Merenstein, M.D., Georgetown University
Georgetown University
  • USDA Beltsville Human Nutrition Research Center
  • Penn State University
Principal Investigator: Daniel Merenstein, MD Georgetown University
Georgetown University
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP