Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Fruit juice with Lactobacillus rhamnosus GG, version 1
Fruit juice with Lactobacillus rhamnosus GG, version 2
Standard fruit juice
Eligibility Criteria
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Exclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
University of Virginia
OTHER
Medcare Ltd
UNKNOWN
Valio Ltd
INDUSTRY
Principal Investigators
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Birgit Winther, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Health System
Locations
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University of Virginia, Respiratory Disease Study Center
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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Valio-73
Identifier Type: -
Identifier Source: org_study_id
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