Manuka honey sinus irrigation for the treatment of chronic rhinosinusitis: a randomized controlled trial.
Victoria S Lee, Ian M Humphreys, Patricia L Purcell...
https://pubmed.ncbi.nlm.nih.gov/27935259Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05427695
Topical Probiotic Sinus Irrigations for the Treatment of Chronic Rhinosinusitis: a Double Blinded Randomized Controlled Trial
Led by University of Illinois at Chicago · Updated on 2026-05-27
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
C
Cures Within Reach
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether topical probiotic sinus irrigations are more effective than saline sinus irrigation in treating active chronic rhinosinusitis (CRS) in patients who have had prior sinus surgery. The study focuses on understanding the role of the sinonasal microbiome, especially targeting harmful bacteria like Staphylococcus aureus and Pseudomonas aeruginosa, and how probiotics might help restore a healthy balance to improve symptoms. Participants will be randomly assigned in a double-blind manner to use either Lactobacillus sakei probiotic nasal irrigation or saline nasal irrigation. Both treatments involve mixing a premeasured packet with 240 mL of distilled water in a NeilMed sinus rinse bottle, administered twice daily for 14 days. The study includes baseline evaluations, assessment immediately after treatment, and follow-up at 6 weeks. During the study, researchers will assess participants through medical history reviews, endoscopic sinus exams, bacterial cultures of the sinuses to analyze bacterial burden and diversity, and symptom surveys including the Sinonasal Outcome Test-22 (SNOT-22) and pain scales. Safety and symptom changes will be monitored throughout the 6-week period after enrollment to better understand treatment impact.
CONDITIONS
Brief Title
Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years of age or older
- Diagnosed with acute exacerbation of chronic rhinosinusitis showing worsening of one or more sinonasal symptoms
- Have undergone functional endoscopic sinus surgery more than 12 months prior with patent sinuses
- Willing to follow study procedures for the duration of the study
- Able to understand study purpose and procedures and sign informed consent
- Adults with active chronic rhinosinusitis regardless of race, gender, or socioeconomic status
You will not qualify if you...
- Currently using topical antibiotic sinus irrigations and unwilling to stop
- Unable to complete self-administered questionnaires due to cognitive impairment, language barrier, or severe medical conditions
- Have terminal illness, immunocompromised status, systemic autoimmune or granulomatous disease affecting sinuses, cystic fibrosis, or recent head/sinonasal trauma
- Have severe or emergent complications from chronic rhinosinusitis or sinus tumors
- Female patients who are pregnant, breastfeeding, or possibly pregnant
- Taking oral corticosteroids or antibiotics within the previous 2 weeks
- Have upper respiratory infection symptoms such as fever, sneezing, runny nose, sore throat, or cough at enrollment; eligible once symptoms resolve if criteria met
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants perform nasal irrigation with either Lactobacillus sakei or isotonic saline solution twice a day for 14 days.
1 baseline visit and 1 visit immediately after treatment completion
Follow-up
Duration - Approximately 6 weeks after treatment
Participants are assessed 6 weeks after initial enrollment to evaluate treatment effects through patient history, endoscopic exams, culture swabs, and symptom surveys.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Illinois Hospitals & Health Sciences System
Chicago, Illinois, United States, 60612
Actively Recruiting
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Research Team
V
Victoria Lee, MD
A
Anthony I Dick, MBBS, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Manuka honey sinus irrigations in recalcitrant chronic rhinosinusitis: phase 1 randomized, single-blinded, placebo-controlled trial.
Mian Li Ooi, Arvind Jothin, Catherine Bennett...
https://pubmed.ncbi.nlm.nih.gov/31461581International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.
Richard R Orlandi, Todd T Kingdom, Peter H Hwang...
https://pubmed.ncbi.nlm.nih.gov/26889651The Potential for Topical Probiotic Treatment of Chronic Rhinosinusitis, a Personal Perspective.
Anders U Cervin
https://pubmed.ncbi.nlm.nih.gov/29379772Characterization of bacterial and fungal biofilms in chronic rhinosinusitis.
Andrew Foreman, Alkis James Psaltis, Lor Wai Tan...
https://pubmed.ncbi.nlm.nih.gov/19958600Probiotics and Disease: A Comprehensive Summary-Part 5, Respiratory Conditions of the Ears, Nose, and Throat.
Margaret G Gasta, Crystal M Gossard, Christy B Williamson...
https://pubmed.ncbi.nlm.nih.gov/30881245Sinus microbiome diversity depletion and Corynebacterium tuberculostearicum enrichment mediates rhinosinusitis.
Nicole A Abreu, Nabeetha A Nagalingam, Yuanlin Song...
https://pubmed.ncbi.nlm.nih.gov/22972842Antagonistic effects of Streptococcus and Lactobacillus probiotics in pharyngeal biofilms.
G J Humphreys, A J McBain
https://pubmed.ncbi.nlm.nih.gov/30776138Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients.
Christiane Forestier, Dominique Guelon, Valérie Cluytens...
https://pubmed.ncbi.nlm.nih.gov/18489775Effect of recolonisation with "interfering" alpha streptococci on recurrences of acute and secretory otitis media in children: randomised placebo controlled trial.
K Roos, E G Håkansson, S Holm
https://pubmed.ncbi.nlm.nih.gov/11159619