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OpenTrials
Completed

NCT Number: NCT01461200

Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females between 18 and 55 years of age.
  • History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
  • For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.

Exclusion criteria

  • Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
  • Use of nasal steroids, antihistamines in the last 4 weeks.
  • Upper respiratory infection, sinusitis less than 2 weeks before screening.
  • Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
  • Participation in other investigational therapy in the last 30 days.
  • Any systemic disorder or medication interfering with the study.
  • Undergoing allergen desensitization therapy.
  • Not willing to give informed consent
  • Inability to understand the nature and requirements of the study, or to comply with the study procedures.
  • Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Treatment and study plan

Swab of vestibule and middle meatus of nose

Other

Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season

Primary outcomes

  1. Change in bacterial profile of the sinuses

    Time frame: Measured at baseline and 1 to 3 months later.

    DNA isolation to determine the bacterial profiles of samples taken at baseline (out of subjects' allergy season) and 1 to 3 months later during subjects' allergy season.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Parallel Group Observational Study of the Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2011
Registry last updated
Mar 27, 2014

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.

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