Rhinovirus Study With Lactobacillus Rhamnosus GG

NCT01229917 | Completed Phase 4

• 1 other identifier: Valio-73
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Tract Infections [C08.730]

Interventions

Fruit juice with Lactobacillus rhamnosus GG, version 1 OTHER

Fruit juice with Lactobacillus rhamnosus GG, version 2 OTHER

Standard fruit juice OTHER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age 18-65 years
• Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
• No clinically significant finding on the pre-study nasal examination
• 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
• Written informed consent must be obtained at enrollment into the study
• Suffer from or have a history of significant allergic rhinitis at the time of study
• Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
• Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
• Pregnancy or lactation
• 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
• Daily smoking within the past 2 years
• Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment
• Previous participation in an experimental study with rhinovirus 39
• Allergy to any ingredient in the study product
• 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

Sponsors & Collaborators

• Valio Ltd: lead
• University of Helsinki: collaborator
• University of Virginia: collaborator
• Medcare Ltd: collaborator

Study Sites (1)

University of Virginia, Respiratory Disease Study Center

Charlottesville, Virginia, United States

Location

MeSH Terms

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Birgit Winther, Dr.

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

US (1)