Rhinovirus Study With Lactobacillus Rhamnosus GG
This study has been completed.
Sponsor:
Valio Ltd
Collaborators:
Helsinki University
University of Virginia
Medcare Ltd
Information provided by:
Valio Ltd
ClinicalTrials.gov Identifier:
NCT01229917
First received: October 26, 2010
Last updated: July 6, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Tract Infections [C08.730] |
Other: Fruit juice with Lactobacillus rhamnosus GG, version 1 Other: Fruit juice with Lactobacillus rhamnosus GG, version 2 Other: Standard fruit juice |
Phase 4 |
| Study Type: | Interventional |
Resource links provided by NLM:
Further study details as provided by Valio Ltd:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229917
Locations
| United States, Virginia | |
| University of Virginia, Respiratory Disease Study Center | |
| Charlottesville, Virginia, United States | |
Sponsors and Collaborators
Valio Ltd
Helsinki University
University of Virginia
Medcare Ltd
Investigators
| Principal Investigator: | Birgit Winther, Dr. | University of Virginia Health System |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01229917 History of Changes |
| Other Study ID Numbers: | Valio-73 |
| Study First Received: | October 26, 2010 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Infection Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013