Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
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ClinicalTrials.gov Identifier: NCT01461200 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : March 27, 2014
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Condition or disease | Intervention/treatment |
---|---|
Allergic Rhinitis | Other: Swab of vestibule and middle meatus of nose |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | A Parallel Group Observational Study of the Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | February 2012 |
Group/Cohort | Intervention/treatment |
---|---|
Non allergics |
Other: Swab of vestibule and middle meatus of nose
Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season |
allergics |
Other: Swab of vestibule and middle meatus of nose
Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season |
- 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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461200
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Robert Naclerio, MD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT01461200 |
Other Study ID Numbers: |
10-712-A |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | March 27, 2014 |
Last Verified: | March 2014 |
Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |