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

NCT01657643 — Not applicable, Completed, 231 participants, University of Medicine and Dentistry of New Jersey

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01657643
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple
Enrollment	231 (Actual)
Sponsor	University of Medicine and Dentistry of New Jersey (Other); collaborators: Novonesis
Conditions	Upper Respiratory Infection
Interventions	Probiotics, placebo (Dietary supplement)
Dates	start 2011-01-01, primary completion 2011-05-01, completion 2011-05-01, first posted 2012-08-06, last updated 2015-05-28
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Dietary Supplement: placebo	Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder)
Probiotics	Experimental	Dietary Supplement: Probiotics	Every day for 12 weeks, subjects are asked to eat 5 grams of a strawberry-flavored candy that contains probiotics \[daily dose minimum of 1 billion CFU of each Lactobacillus rhamnosus LGG® (LGG®), and Bifidobacterium animalis ssp lactis BB-12® (BB-12®)\]

Probiotics (Dietary supplement), also known as Lactobacillus rhamnosus LGG® (LGG®), Bifidobacterium animalis ssp lactis BB-12® (BB-12®)
placebo (Dietary supplement)

+Outcome measures

Primary outcomes

Health-related quality of life [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.

Secondary outcomes

Missed work days [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.

Other outcomes

Missed school days [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.

+Eligibility

Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers

Inclusion Criteria:

1. Student at Framingham State University (Framingham, MA)
2. Live in on-campus housing

Exclusion Criteria:

1. their driver's license or state identification card indicated that they were under 18 years of age or over 25 years of age;
2. 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.

+Locations (1)

Facility	City	Country	Status
Framingham State University	Framingham, Massachusetts	United States

+Investigators

Tracey J Smith, PhD, Principal investigator, University of Medicine and Dentistry of New Jersey