Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Lactobacillus Rhamnosus LGG® and Bifidobacterium Animalis Ssp Lactis BB-12® on Health-related Quality of Life in College Students With Upper Respiratory Infections

Conditions
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Upper Respiratory Infection

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Student at Framingham State University (Framingham, MA) Live in on-campus housing Exclusion Criteria: their driver's license or state identification card indicated that they were under 18 years of age or over 25 years of age; they experienced chronic perennial allergies (such as, allergies to dust or 3) they were pregnant 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder) | Dietary Supplement: placebo<br> <br> |
| Experimental: Probiotics<br>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®)] | Dietary Supplement: Probiotics<br> <br> * Other names: Bifidobacterium animalis ssp lactis BB-12® (BB-12®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health related quality of life, Functional Status