Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

May 21, 2026 updated by: Victoria S. Lee, University of Illinois at Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Victoria Lee, MD
  • Phone Number: 312.996.6582
  • Email: vlee39@uic.edu

Study Contact Backup

  • Name: Anthony I Dick, MBBS, MPH
  • Phone Number: 312-492-5001
  • Email: adick@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospitals & Health Sciences System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline Nasal Irrigation (Control)
Patients will perform nasal irrigation with an isotonic saline solution, using a 240ml NeilMed sinus rinse bottle, 2 times/day for 14 days. A blinded packet supplied by IDS containing a premeasured amount of saline to be mixed with 240ml of distilled water will be provided to patients for each irrigation.
Other: Isotonic Saline Solution
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.
Other Names:
  • NeilMed Isotonic Sinus Rinse
Experimental: Lactobacillus sakei nasal irrigation
Patients will perform nasal irrigation with Lactobacillus sakei, using a 240ml NeilMed sinus rinse bottle, 2 times/day for 14 days. A blinded packet provided by IDS containing a premeasured amount of Lactobacillus sakei to be mixed with 240ml of distilled water will be provided to patients for each irrigation.
Drug: Lactobacillus sakei proBio65
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.
Other Names:
  • Lanto Sinus Probiotic Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinonasal Outcome Test-22 (SNOT-22)
Time Frame: 6 weeks
It is expected that topical probiotic irrigations will result in a clinically significant change in symptom severity score (SNOT-22) (a change of 9 on a scale 0-110) compared to saline irrigations (primary outcome).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus microbiota
Time Frame: 6 weeks
Nasal swab samples will be assessed for the number of bacteria present before and after treatment. Bacterial DNA will be extracted from nasal swabs. The purified DNA will be quantified for concentration using a Qubit fluorometer (Invitrogen, CA, USA) before storing at -20°C until further use. Bacterial burden will be determined by quantitative PCR (qPCR) using universal 16S ribosomal RNA primers. Additionally, each nasal swab will be assessed for bacteria taxonomic distribution by NGS using the MiSeq NGS platform (Illumina) before and after treatment. MiSeq paired-end sequencing of the hypervariable V3-V4 regions of the 16S rRNA gene (primers 341F/785R) will be performed.
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund-Kennedy Score
Time Frame: 6 weeks
It is expected that topical probiotic irrigations will result in lower scores than sinus irrigations based on the Lund-Kennedy (LK) Endoscopic Scoring System. The LK system is used to evaluate sinus polyps, edema, discharge scarring and crusting. Scores range from 0 to 20. Lower scores mean a better outcome.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Cures Within Reach

Investigators

  • Principal Investigator: Victoria Lee, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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