Using probiotics in nasal irrigation to treat chronic sinusitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Victoria Lee, MD — University of Illinois Chicago
• Study coordinator: Victoria Lee, MD
• Email: vlee39@uic.edu
• Phone: 312.996.6582

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.