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

This study has been completed.
Sponsor:
Collaborator:
Chr Hansen A/S
Information provided by (Responsible Party):
SHRP nutritional sciences, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01657643
First received: July 28, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Upper Respiratory Infection
 Dietary Supplement: Probiotics
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Health-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Missed work days [ Time Frame: Once per week over the course of 12 weeks ] [ Designated as safety issue: No ]
    Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed work days.


Other Outcome Measures:
  • Missed school days [ Time Frame: Once per week over the course of 12 weeks ] [ Designated as safety issue: No ]
    Once per week, for 12 weeks, subjects are asked to complete a questionnaire that inquires about missed school days.


Enrollment: 231
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®)

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657643

Locations
United States, Massachusetts
Framingham State University
Framingham, Massachusetts, United States, 01701
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Chr Hansen A/S
Investigators
Principal Investigator: Tracey J Smith, PhD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: SHRP nutritional sciences, Tracey J. Smith, Doctoral Student, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01657643     History of Changes
Other Study ID Numbers: 0120100395
Study First Received: July 28, 2012
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Health related quality of life
Functional Status

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013