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| Name | Class |
|---|---|
| Novonesis | INDUSTRY |
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The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt) can improve the health-related quality of life (HRQL) during upper respiratory infections (like the common cold) in college students living in residence hall on-campus at Framingham State University (Framingham, MA) who are randomized to receive a probiotic or placebo candy daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of quality of life (i.e., one's satisfaction with their life) that related specifically to a person's health (for example, ability to carry out normal daily activities). The investigators hypothesize that HRQL during URIs will be significantly higher in the probiotic groups compared to the placebo group. The proposed study will also seek to address the following secondary objectives: missed school and work days due to a upper respiratory infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder) |
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| Probiotics | Experimental | Every day for 12 weeks, subjects are asked to eat 5 grams of a strawberry-flavored candy that contains probiotics [daily dose minimum of 1 billion CFU of each Lactobacillus rhamnosus LGG® (LGG®), and Bifidobacterium animalis ssp lactis BB-12® (BB-12®)] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Subjects are asked to complete a questionnaire every day for 12 weeks that inquires about any common cold symptoms that they may be experiencing, severity of the symptoms, and how the symptoms interfere with their daily activities. Health-related quality of life is operationalized by total score on the questionnaire. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Missed work days | Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed work days. | Once per week over the course of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Missed school days | Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed school days. | Once per week over the course of 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
4) they had been diagnosed with medical conditions affecting immune function (for example, asthma, chronic fatigue syndrome and human immunodeficiency virus) 5) they had acute pancreatitis, were undergoing treatment for cancer; or, were taking immunosuppressive drugs for an autoimmune disease or post-transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Tracey J Smith, PhD | University of Medicine and Dentistry of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Framingham State University | Framingham | Massachusetts | 01701 | United States |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| placebo | Dietary Supplement |
|
| D019602 |
| Food and Beverages |