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Completed

NCT Number: NCT01657643

Effect of Probiotics 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.

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Key information

Conditions

Upper Respiratory Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Framingham State University

Framingham, Massachusetts, 01701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student at Framingham State University (Framingham, MA)
  • Live in on-campus housing

Exclusion criteria

  • their driver's license or state identification card indicated that they were under 18 years of age or over 25 years of age;
  • they experienced chronic perennial allergies (such as, allergies to dust or 3) they were pregnant
  • 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.

Treatment and study plan

Probiotics

Dietary Supplement

Other names: Lactobacillus rhamnosus LGG® (LGG®), Bifidobacterium animalis ssp lactis BB-12® (BB-12®)

Placebo

Dietary Supplement

Primary outcomes

  1. Health-related quality of life

    Time frame: 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

  1. Missed work days

    Time frame: 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

  1. Missed school days

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Novonesis

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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