A Study to Treat Chronic Rhinosinusitis by Transplanting Probiotic Communites
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-008609
Sponsor Protocol Number: 16-008609
About this study
The purpose of this study is to identify differences in the sinus microbiota in patients with chronic rhinosinusitis (CRS) and determine potential immunological targets of CRS-associated pathogenic communities.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients presenting to the PI’s clinic will be offered enrollment if their problem requires examination of the sinonasal area.
- Bed partners: Monogamous partners that share a bed at least 4 nights each week (if applicable).
- Control subjects: Patients that do not have sinusitis but are being seen in clinic for other medical problems and require a transnasal examination.
- A written, informed consent will be obtained.
- Subjects of either gender and of all races will be enrolled.
Exclusion Criteria:
- Patients unwilling or unable to undergo nasal endoscopy or CT scan.
- Pregnant women.
- Patients on chronic oral steroid therapy.
- Prisoners and institutionalized patients.
- Patients at very high risk of bleeding due to elevated bleeding profile, being on multiple blood thinners or significant thrombocytopenia.
- Patients with neutropenia or those deemed clinically to be significantly vulnerable to post-biopsy infection.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Devyani Lal, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available