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

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Infection
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Probiotics

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Framingham, Massachusetts, United States, 01701
      • Framingham State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
EXPERIMENTAL: 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®)]	Dietary supplement: Probiotics; Other Names: Lactobacillus rhamnosus LGG® (LGG®); Bifidobacterium animalis ssp lactis BB-12® (BB-12®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: Chr Hansen
• Investigators: Principal Investigator: Tracey J Smith, PhD, University of Medicine and Dentistry of New Jersey

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: July 28, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (ESTIMATE): August 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Functional Status; Health related quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 0120100395