Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
Topical Probiotic Sinus Irrigations for the Treatment of Chronic Rhinosinusitis: a Double Blinded Randomized Controlled Trial
University of Illinois at Chicago
60 participants
Feb 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Male and female patients 18 years of age or older.
- 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.
- 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.
- Patients must be willing to follow study related procedures for the duration of the study.
- Patients must understand the purpose and procedures and be willing to sign the study informed consent document.
- 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 Criteria6
- Patients who are taking topical antibiotic irrigations and are unwilling to stop them.
- Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions.
- 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.
- Patients who have severe or emergent complications from CRS or presence of a sinus tumor.
- 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).
- Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.
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Interventions
Lanto Sinus probiotic Lactobacillus sakei is a currently available over the counter supplement from the common source kimchi and produced in South Korea. Patients will be instructed to mix 1 packet with lukewarm distilled or boiled water in 240mL NeilMed® sinus rinse bottle.
Saline sinus irrigations (SAL group): NeilMed® Isotonic Sinus Rinse™ is marketed as a saline sinus irrigation formula. Subjects will be given instructions to mix one unlabeled packet (containing NeilMed® premixed buffered salt powder) with lukewarm distilled or boiled water in 240mL NeilMed® sinus rinse bottle.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05427695