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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Children given probiotic BB12 enriched yogurt drink. |
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| Control | Placebo Comparator | Children given dairy drink. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt drink with probiotic bacteria BB12 | Other | Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization and illness related costs as measured by number of physician visits, ER visits, hospitalizations, and antibiotics use. Also, child growth and quality of life. Exploratory biomarker outcomes in stool. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamar Ringel-Kulka, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, School of Public Health | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25841539 | Derived | Ringel-Kulka T, Kotch JB, Jensen ET, Savage E, Weber DJ. Randomized, double-blind, placebo-controlled study of synbiotic yogurt effect on the health of children. J Pediatr. 2015 Jun;166(6):1475-81.e1-3. doi: 10.1016/j.jpeds.2015.02.038. Epub 2015 Apr 1. |
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| Placebo | Other | Vanilla flavored dairy drink. One bottle a day for 16 weeks. |
|