Using probiotics in nasal irrigation to treat chronic sinusitis

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

This study is testing if using a probiotic nasal rinse can help people with chronic sinusitis feel better after they've had sinus surgery, compared to using a regular saline rinse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05427695 on ClinicalTrials.gov

What this trial studies

This randomized study aims to evaluate the effectiveness of topical probiotic sinus irrigations compared to saline controls in treating chronic rhinosinusitis (CRS) in patients who have previously undergone sinus surgery. The study hypothesizes that probiotics can restore the sinonasal microbiome by outcompeting pathogenic bacteria, thereby improving patient outcomes. Participants will be randomly assigned to receive either Lactobacillus sakei or saline nasal irrigation twice daily for 14 days, with assessments conducted before treatment, immediately after, and six weeks later. The study will measure both subjective and objective outcomes to determine the efficacy of the probiotic intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with active chronic rhinosinusitis who have had prior sinus surgery.

Not a fit: Patients currently using topical antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from chronic sinusitis.

How similar studies have performed: While the use of probiotics in sinus treatments is a relatively novel approach, similar studies have shown promising results in other areas of microbiome research.

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.

Where this trial is running

Chicago, Illinois

• University of Illinois Hospitals & Health Sciences System — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Victoria Lee, MD — University of Illinois at Chicago
• Study coordinator: Victoria Lee, MD

Conditions Chronic Rhinosinusitis