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Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

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

NCT01461200•University of Chicago

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males and females between 18 and 55 years of age.
•2. History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
•3. 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

•1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
•2. Use of nasal steroids, antihistamines in the last 4 weeks.
•3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
•4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
•5. Participation in other investigational therapy in the last 30 days.
•6. Any systemic disorder or medication interfering with the study.
•7. Undergoing allergen desensitization therapy.
•8. Not willing to give informed consent
•9. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
•10. 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.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

March 1, 2011

Primary Completion Date

January 1, 2012

Completion Date

February 1, 2012

Last Updated

March 27, 2014

Enrollment

ACTUAL participants

Conditions

Allergic Rhinitis

Interventions

Swab of vestibule and middle meatus of nose

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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