Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections
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.
Upper Respiratory Infection
Dietary Supplement: Probiotics
Dietary Supplement: placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
|Official Title:||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|
- Health-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Missed work days [ Time Frame: Once per week over the course of 12 weeks ] [ Designated as safety issue: No ]Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed work days.
- Missed school days [ Time Frame: Once per week over the course of 12 weeks ] [ Designated as safety issue: No ]Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed school days.
|Study Start Date:||January 2011|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder)
|Dietary Supplement: placebo|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657643
|United States, Massachusetts|
|Framingham State University|
|Framingham, Massachusetts, United States, 01701|
|Principal Investigator:||Tracey J Smith, PhD||University of Medicine and Dentistry of New Jersey|