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

Upper Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657643
• Other study ID #: 0120100395
• Status: Completed
• Phase: N/A
• First received: July 28, 2012
• Last updated: May 26, 2015
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: May 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Dietary Supplement:
• Probiotics

• placebo

Locations

Country	Name	City	State
United States	Framingham State University	Framingham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Chr Hansen A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Missed school days	Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed school days.	Once per week over the course of 12 weeks	No
Primary	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	No
Secondary	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	No