RECRUITING

Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

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Conditions

Chronic Rhinosinusitis (Diagnosis)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this randomized study will be to determine whether topical probiotic sinus irrigations are more effective compared to saline sinus irrigation controls in the treatment of active CRS in patients who have had prior sinus surgery based on subjective and objective outcome measures.

Official Title

Topical Probiotic Sinus Irrigations for the Treatment of Chronic Rhinosinusitis: a Double Blinded Randomized Controlled Trial

Quick Facts

Study Start:2025-02-05
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05427695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female patients 18 years of age or older.
  2. 2. Patients diagnosed with acute exacerbation of CRS, defined by worsening of 1 or more sinonasal symptoms (nasal obstruction/congestion, nasal discharge, facial pain/pressure, reduced sense of smell) and inflammatory and/or infectious changes on sinus endoscopy.
  3. 3. Patients that have undergone functional endoscopic sinus surgery \> 12 months prior to enrollment as documented in the patients electronic medical record, with patent sinuses deemed suitable for trial on investigator's discretion.
  4. 4. Patients must be willing to follow study related procedures for the duration of the study.
  5. 5. Patients must understand the purpose and procedures and be willing to sign the study informed consent document.
  6. 6. All adult men and women with active CRS will be considered for participation in this study without regard to race, gender, or socioeconomic status.
  1. 1. Patients who are taking topical antibiotic irrigations and are unwilling to stop them.
  2. 2. Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions.
  3. 3. Patients who have a terminal illness (malignancy), immunocompromised (medication-related immunosuppression, immunodeficiency disorder) or systemic disease (granulomatosis polyangiitis or other autoimmune disease with sinonasal manifestations, cystic fibrosis), or recent head/sinonasal trauma that may predispose to infectious complications.
  4. 4. Patients who have severe or emergent complications from CRS or presence of a sinus tumor.
  5. 5. Female patients who are pregnant or breastfeeding. The patient will be asked if she is pregnant or has any chance of being pregnant. In either case, the patient will be excluded. Note in our consent form this is also addressed (excerpt below).
  6. 6. Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.
  7. 7. Patients who have upper respiratory infection-type symptoms at time of enrollment, e.g., fevers/chills, sneezing, runny nose, sore throat, coughing. Patients can be eligible for enrollment once symptoms have fully resolved if all other inclusion/exclusion criteria are met.

Contacts and Locations

Study Contact

Victoria Lee, MD
CONTACT
312.996.6582
vlee39@uic.edu
Ginevra Ciavarella, Ph.D.
CONTACT
312.996.6582
gciava1@uic.edu

Principal Investigator

Victoria Lee, MD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Illinois Hospitals & Health Sciences System
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Victoria Lee, MD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-05
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2025-02-05
Study Completion Date2026-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Rhinosinusitis (Diagnosis)