Respiratory Tract Infections [C08.730] Clinical Trial
| NCT number | NCT01229917 |
| Other study ID # | Valio-73 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | October 26, 2010 |
| Last updated | July 6, 2011 |
| Verified date | July 2011 |
| Source | Valio Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the 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 Exclusion Criteria: 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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia, Respiratory Disease Study Center | Charlottesville | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Valio Ltd | Helsinki University, Medcare Ltd, University of Virginia |
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