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

July 28, 2012
August 3, 2012
January 2011
May 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01657643 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Upper Respiratory Infection
  • Dietary Supplement: Probiotics
    Other Names:
    • Lactobacillus rhamnosus LGG® (LGG®)
    • Bifidobacterium animalis ssp lactis BB-12® (BB-12®)
  • Dietary Supplement: placebo
  • Placebo Comparator: Placebo
    Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder)
    Intervention: 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®)]
    Intervention: Dietary Supplement: Probiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
May 2011
May 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01657643
0120100395
No
SHRP nutritional sciences, University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
Chr Hansen A/S
Principal Investigator: Tracey J Smith, PhD University of Medicine and Dentistry of New Jersey
Rutgers, The State University of New Jersey
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP