Rhinovirus Study With Lactobacillus Rhamnosus GG
Primary Purpose
Respiratory Tract Infections [C08.730]
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fruit juice with Lactobacillus rhamnosus GG, version 1
Fruit juice with Lactobacillus rhamnosus GG, version 2
Standard fruit juice
Sponsored by
About this trial
This is an interventional trial for Respiratory Tract Infections [C08.730]
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Virginia, Respiratory Disease Study Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01229917
First Posted
October 26, 2010
Last Updated
July 6, 2011
Sponsor
Valio Ltd
Collaborators
University of Helsinki, University of Virginia, Medcare Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01229917
Brief Title
Rhinovirus Study With Lactobacillus Rhamnosus GG
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Valio Ltd
Collaborators
University of Helsinki, University of Virginia, Medcare Ltd
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections [C08.730]
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Fruit juice with Lactobacillus rhamnosus GG, version 1
Intervention Type
Other
Intervention Name(s)
Fruit juice with Lactobacillus rhamnosus GG, version 2
Intervention Type
Other
Intervention Name(s)
Standard fruit juice
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Winther, Dr.
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia, Respiratory Disease Study Center
City
Charlottesville
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rhinovirus Study With Lactobacillus Rhamnosus GG
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