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OpenTrials
Completed

NCT Number: NCT01229917

Rhinovirus Study With Lactobacillus Rhamnosus GG

The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Virginia, Respiratory Disease Study Center

Charlottesville, Virginia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit juice with Lactobacillus rhamnosus GG, version 1

Other

Fruit juice with Lactobacillus rhamnosus GG, version 2

Other

Standard fruit juice

Other

Sponsors and collaborators

Lead sponsor

Valio Ltd

Industry

Collaborators

  • Medcare Ltd
  • University of Helsinki
  • University of Virginia

Registry information

Important dates

First posted
Oct 28, 2010
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.