Rhinovirus Study With Lactobacillus Rhamnosus GG

The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections [C08.730]
• Intervention / Treatment: Other: Fruit juice with Lactobacillus rhamnosus GG, version 1; Other: Fruit juice with Lactobacillus rhamnosus GG, version 2; Other: Standard fruit juice

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia, Respiratory Disease Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
2. Age 18-65 years
3. Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
4. No clinically significant finding on the pre-study nasal examination
5. Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms
6. Written informed consent must be obtained at enrollment into the study

Exclusion Criteria:

1. Suffer from or have a history of significant allergic rhinitis at the time of study
2. Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
3. Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
4. Pregnancy or lactation
5. History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment
6. Daily smoking within the past 2 years
7. Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment
8. Previous participation in an experimental study with rhinovirus 39
9. Allergy to any ingredient in the study product
10. Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Valio Ltd
• Collaborators: University of Virginia; University of Helsinki; Medcare Ltd
• Investigators: Principal Investigator: Birgit Winther, Dr., University of Virginia Health System

Study record dates

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: Valio-73