Rhinovirus Study With Lactobacillus Rhamnosus GG

NCT ID: NCT01229917

Last Updated: 2011-07-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Tract Infections [C08.730]

Interventions

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Fruit juice with Lactobacillus rhamnosus GG, version 1

Intervention Type OTHER

Fruit juice with Lactobacillus rhamnosus GG, version 2

Intervention Type OTHER

Standard fruit juice

Intervention Type OTHER

Eligibility Criteria

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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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

Medcare Ltd

UNKNOWN

Sponsor Role collaborator

Valio Ltd

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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United States

Other Identifiers

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Valio-73

Identifier Type: -

Identifier Source: org_study_id

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