Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections
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
1 other identifier
interventional
231
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 6, 2012
CompletedMay 28, 2015
May 1, 2015
4 months
July 28, 2012
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Missed work days
Once per week over the course of 12 weeks
Other Outcomes (1)
Missed school days
Once per week over the course of 12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATOREvery day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder)
Probiotics
EXPERIMENTALEvery day for 12 weeks, subjects are asked to eat 5 grams of a strawberry-flavored candy that contains probiotics \[daily dose minimum of 1 billion CFU of each Lactobacillus rhamnosus LGG® (LGG®), and Bifidobacterium animalis ssp lactis BB-12® (BB-12®)\]
Interventions
Eligibility Criteria
You may qualify if:
- Student at Framingham State University (Framingham, MA)
- Live in on-campus housing
You may not qualify if:
- 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
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Medicine and Dentistry of New Jerseylead
- Chr Hansen A/Scollaborator
Study Sites (1)
Framingham State University
Framingham, Massachusetts, 01701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracey J Smith, PhD
University of Medicine and Dentistry of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tracey J. Smith, Doctoral Student
Study Record Dates
First Submitted
July 28, 2012
First Posted
August 6, 2012
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 28, 2015
Record last verified: 2015-05