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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
Valio Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Respiratory Tract Infections [C08.730]

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia, Respiratory Disease Study Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 26, 2010
Last Updated
July 6, 2011
Sponsor
Valio Ltd
Collaborators
University of Helsinki, University of Virginia, Medcare Ltd
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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

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Rhinovirus Study With Lactobacillus Rhamnosus GG

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