Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections
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|ClinicalTrials.gov Identifier: NCT01657643|
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Infection||Dietary Supplement: Probiotics Dietary Supplement: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, 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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
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
- Health-related quality of life [ Time Frame: 12 weeks ]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 ]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 ]Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed school days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|