Yogurt Study in Children 2-4 Years Old Attending Daycare (SIPPY II)
This study has been completed.
Sponsor:
Georgetown University
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
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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:
- Give their child 4 oz. of the test yogurt each day for 90 days
- Keep a daily diary of their child's health
- Collect 3 stool samples from their child at the start, middle, and end of the study
- Speak with research personnel on a bi-weekly basis regarding their child's health
- 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
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 June 18, 2013