RecruitingPhase 2NCT05427695

Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

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


Sponsor

University of Illinois at Chicago

Enrollment

60 participants

Start Date

Feb 5, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rinsing the sinuses with a probiotic solution (good bacteria) can help people who have ongoing sinus problems — a condition called chronic rhinosinusitis (CRS). Participants have already had sinus surgery and are currently experiencing a flare-up. Researchers want to see if probiotics can reduce inflammation and infection compared to a regular rinse. You may be eligible if... - You are 18 years of age or older - You have been diagnosed with chronic rhinosinusitis with a current flare-up - You had functional endoscopic sinus surgery more than 12 months ago and your sinuses are open - You are willing and able to follow study procedures and complete questionnaires You may NOT be eligible if... - You are currently using topical antibiotic rinses and are unwilling to stop - You have a terminal illness, are immunocompromised, or have cystic fibrosis or certain autoimmune diseases - You are pregnant or breastfeeding - You have taken oral antibiotics or corticosteroids in the past 2 weeks - You currently have symptoms of an upper respiratory infection (fever, runny nose, sore throat) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLactobacillus 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.

OTHERIsotonic 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.


Locations(1)

University of Illinois Hospitals & Health Sciences System

Chicago, Illinois, United States

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NCT05427695


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