NCT05427695 Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
| NCT ID | NCT05427695 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Chronic Rhinosinusitis (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-02-05 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male and female patients 18 years of age or older. 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. 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. Patients must be willing to follow study related procedures for the duration of the study. 5. Patients must understand the purpose and procedures and be willing to sign the study informed consent document. 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. Exclusion Criteria: 1. Patients who are taking topical antibiotic irrigations and are unwilling to stop them. 2. Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions. 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. Patients who have severe or emergent complications from CRS or presence of a sinus tumor. 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. Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids. 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.
Contact & Investigator
Victoria Lee, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT05427695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05427695 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05427695 currently recruiting?
Yes, NCT05427695 is actively recruiting participants. Contact the research team at vlee39@uic.edu for enrollment information.
Where is the NCT05427695 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05427695 clinical trial?
NCT05427695 is sponsored by University of Illinois at Chicago. The principal investigator is Victoria Lee, MD at University of Illinois at Chicago. The trial plans to enroll 60 participants.