Rhinovirus Study With Lactobacillus Rhamnosus GG

Status:

COMPLETED

Rhinovirus Study With Lactobacillus Rhamnosus GG

Lead Sponsor:

Valio Ltd

Collaborating Sponsors:

University of Helsinki

University of Virginia

Conditions:

Respiratory Tract Infections [C08.730]

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01229917

Last Update

July 7 2011

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