Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

Last updated: April 8, 2025
Sponsor: University of Illinois at Chicago
Overall Status: Active - Recruiting

Phase

2

Condition

Sinus Infections

Soft Tissue Infections

Nasal Obstruction

Treatment

Isotonic Saline Solution

Lactobacillus sakei proBio65

Clinical Study ID

NCT05427695
2021-1205
  • Ages > 18
  • All Genders

Study 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

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 moresinonasal symptoms (nasal obstruction/congestion, nasal discharge, facialpain/pressure, reduced sense of smell) and inflammatory and/or infectious changes onsinus endoscopy.

  3. 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.

  4. Patients must be willing to follow study related procedures for the duration of thestudy.

  5. Patients must understand the purpose and procedures and be willing to sign the studyinformed consent document.

  6. 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:

  1. Patients who are taking topical antibiotic irrigations and are unwilling to stopthem.

  2. Patients who are unable to complete self-administered questionnaires because ofcognitive impairment, language barrier, or severe medical conditions.

  3. 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.

  4. Patients who have severe or emergent complications from CRS or presence of a sinustumor.

  5. 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).

  6. Patients who are taking oral corticosteroids or who have taken oral antibiotics inthe 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 beeligible for enrollment once symptoms have fully resolved if all otherinclusion/exclusion criteria are met.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Isotonic Saline Solution
Phase: 2
Study Start date:
February 05, 2025
Estimated Completion Date:
July 30, 2026

Study Description

CRS is a common clinical entity with estimated prevalence ranging from 14-16% in the community. The most commonly implicated pathogenic bacteria in recalcitrant patients are Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa). In recent years, there has been an increasing focus on the commensal sinonasal microbiome and its role in the development of a functional immune system. It has been theorized that infections in CRS may be related to a decrease in diversity of the commensal microbiome and an increase in these pathogenic bacteria. The concept behind the therapeutic potential of topical probiotics is that they outcompete pathogenic bacteria via a variety of mechanisms, including creating suboptimal environmental conditions, competing for cell surface receptors and thus limiting pathogen adherence, and producing antibacterial metabolites. In doing so, topical probiotics restore the commensal microbiome.

For this study, after being informed about the study and potential risks, all patients meeting eligibility criteria and giving written informed consent will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to Lactobacillus sakei or saline nasal irrigation, twice a day for 14 days.

Patient assessments will occur before treatments begin, immediately after the completion of nasal irrigations, and 6 weeks after initial enrollment. Assessments will be based on patient history, endoscopic exams, culture swab of the sinuses (bacterial burden and number of taxa, SNOT-22 survey, and a visual analog scale to record pain scores.

Connect with a study center

  • University of Illinois Hospitals & Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

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