Rhinovirus Study With Lactobacillus Rhamnosus GG

This study has been completed.
Sponsor:
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

October 26, 2010
July 6, 2011
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Complete list of historical versions of study NCT01229917 on ClinicalTrials.gov Archive Site
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Rhinovirus Study With Lactobacillus Rhamnosus GG
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The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.

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Interventional
Phase 4
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01229917
Valio-73
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Valio Ltd
  • Helsinki University
  • University of Virginia
  • Medcare Ltd
Principal Investigator: Birgit Winther, Dr. University of Virginia Health System
Valio Ltd
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP