Phase
Condition
Sinus Infections
Soft Tissue Infections
Nasal Obstruction
Treatment
Isotonic Saline Solution
Lactobacillus sakei proBio65
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female patients 18 years of age or older.
Patients diagnosed with acute exacerbation of CRS, defined by worsening of 1 or moresinonasal symptoms (nasal obstruction/congestion, nasal discharge, facialpain/pressure, reduced sense of smell) and inflammatory and/or infectious changes onsinus endoscopy.
Patients that have undergone functional endoscopic sinus surgery > 12 months priorto enrollment as documented in the patients electronic medical record, with patentsinuses deemed suitable for trial on investigator's discretion.
Patients must be willing to follow study related procedures for the duration of thestudy.
Patients must understand the purpose and procedures and be willing to sign the studyinformed consent document.
All adult men and women with active CRS will be considered for participation in thisstudy without regard to race, gender, or socioeconomic status.
Exclusion
Exclusion Criteria:
Patients who are taking topical antibiotic irrigations and are unwilling to stopthem.
Patients who are unable to complete self-administered questionnaires because ofcognitive impairment, language barrier, or severe medical conditions.
Patients who have a terminal illness (malignancy), immunocompromised (medication-related immunosuppression, immunodeficiency disorder) or systemicdisease (granulomatosis polyangiitis or other autoimmune disease with sinonasalmanifestations, cystic fibrosis), or recent head/sinonasal trauma that maypredispose to infectious complications.
Patients who have severe or emergent complications from CRS or presence of a sinustumor.
Female patients who are pregnant or breastfeeding. The patient will be asked if sheis pregnant or has any chance of being pregnant. In either case, the patient will beexcluded. Note in our consent form this is also addressed (excerpt below).
Patients who are taking oral corticosteroids or who have taken oral antibiotics inthe previous 2 weeks or on oral corticosteroids.
Patients who have upper respiratory infection-type symptoms at time of enrollment,e.g., fevers/chills, sneezing, runny nose, sore throat, coughing. Patients can beeligible for enrollment once symptoms have fully resolved if all otherinclusion/exclusion criteria are met.
Study Design
Study Description
Connect with a study center
University of Illinois Hospitals & Health Sciences System
Chicago, Illinois 60612
United StatesActive - Recruiting
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