Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

• ClinicalTrials.gov Identifier: NCT01461200
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Last Update Posted: March 27, 2014
• Sponsor: University of Chicago
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Allergic Rhinitis	Other: Swab of vestibule and middle meatus of nose

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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

Study Population

Patients with seasonal allergies and healthy controls from the community.

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Robert Naclerio, MD; University of Chicago

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01461200
• Other Study ID Numbers: 10-712-A
• First Posted: October 28, 2011
• Last Update Posted: March 27, 2014
• Last Verified: March 2014

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases