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

University of Medicine and Dentistry of New Jersey

Status: Completed

Conditions: Upper Respiratory Infection

Treatments: Dietary Supplement: placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01657643

0120100395

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

231 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Every day for 12 weeks, subjects are asked to eat 5 grams of a placebo (strawberry-flavored candy powder)

Treatment:

Dietary Supplement: placebo

Probiotics

Experimental group

Description:

Every day for 12 weeks, subjects are asked to eat 5 grams of a strawberry-flavored candy that contains probiotics \[daily dose minimum of 1 billion CFU of each Lactobacillus rhamnosus LGG® (LGG®), and Bifidobacterium animalis ssp lactis BB-12® (BB-12®)\]

Treatment:

Dietary Supplement: Probiotics