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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
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014