Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

NCT05427695 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2021-1205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Sinonasal Outcome Test-22 (SNOT-22)

  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 Outcomes (1)

• Sinus microbiota

  6 weeks

Other Outcomes (1)

• Lund-Kennedy Score

  6 weeks

Study Arms (2)

Saline Nasal Irrigation (Control)

ACTIVE COMPARATOR

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

Lactobacillus sakei nasal irrigation

EXPERIMENTAL

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

Interventions

Lactobacillus sakei proBio65 DRUG

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.

Also known as: Lanto Sinus Probiotic Powder

Lactobacillus sakei nasal irrigation

Isotonic Saline Solution OTHER

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.

Also known as: NeilMed Isotonic Sinus Rinse

Saline Nasal Irrigation (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18 years of age or older.
• 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.
• 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.
• Patients must be willing to follow study related procedures for the duration of the study.
• Patients must understand the purpose and procedures and be willing to sign the study informed consent document.
• All adult men and women with active CRS will be considered for participation in this study without regard to race, gender, or socioeconomic status.

You may not qualify if:

• Patients who are taking topical antibiotic irrigations and are unwilling to stop them.
• Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions.
• 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.
• Patients who have severe or emergent complications from CRS or presence of a sinus tumor.
• 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).
• Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Cures Within Reach: collaborator

Study Sites (1)

University of Illinois Hospitals & Health Sciences System

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (15)

• Lee VS, Humphreys IM, Purcell PL, Davis GE. Manuka honey sinus irrigation for the treatment of chronic rhinosinusitis: a randomized controlled trial. Int Forum Allergy Rhinol. 2017 Apr;7(4):365-372. doi: 10.1002/alr.21898. Epub 2016 Dec 9.

  PMID: 27935259 BACKGROUND

• Ooi ML, Jothin A, Bennett C, Ooi EH, Vreugde S, Psaltis AJ, Wormald PJ. Manuka honey sinus irrigations in recalcitrant chronic rhinosinusitis: phase 1 randomized, single-blinded, placebo-controlled trial. Int Forum Allergy Rhinol. 2019 Dec;9(12):1470-1477. doi: 10.1002/alr.22423. Epub 2019 Aug 28.

  PMID: 31461581 BACKGROUND

• Orlandi RR, Kingdom TT, Hwang PH, Smith TL, Alt JA, Baroody FM, Batra PS, Bernal-Sprekelsen M, Bhattacharyya N, Chandra RK, Chiu A, Citardi MJ, Cohen NA, DelGaudio J, Desrosiers M, Dhong HJ, Douglas R, Ferguson B, Fokkens WJ, Georgalas C, Goldberg A, Gosepath J, Hamilos DL, Han JK, Harvey R, Hellings P, Hopkins C, Jankowski R, Javer AR, Kern R, Kountakis S, Kowalski ML, Lane A, Lanza DC, Lebowitz R, Lee HM, Lin SY, Lund V, Luong A, Mann W, Marple BF, McMains KC, Metson R, Naclerio R, Nayak JV, Otori N, Palmer JN, Parikh SR, Passali D, Peters A, Piccirillo J, Poetker DM, Psaltis AJ, Ramadan HH, Ramakrishnan VR, Riechelmann H, Roh HJ, Rudmik L, Sacks R, Schlosser RJ, Senior BA, Sindwani R, Stankiewicz JA, Stewart M, Tan BK, Toskala E, Voegels R, Wang de Y, Weitzel EK, Wise S, Woodworth BA, Wormald PJ, Wright ED, Zhou B, Kennedy DW. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb;6 Suppl 1:S22-209. doi: 10.1002/alr.21695.

  PMID: 26889651 BACKGROUND

• Cervin AU. The Potential for Topical Probiotic Treatment of Chronic Rhinosinusitis, a Personal Perspective. Front Cell Infect Microbiol. 2018 Jan 12;7:530. doi: 10.3389/fcimb.2017.00530. eCollection 2017.

  PMID: 29379772 BACKGROUND

• Foreman A, Psaltis AJ, Tan LW, Wormald PJ. Characterization of bacterial and fungal biofilms in chronic rhinosinusitis. Am J Rhinol Allergy. 2009 Nov-Dec;23(6):556-61. doi: 10.2500/ajra.2009.23.3413.

  PMID: 19958600 BACKGROUND

• Gasta MG, Gossard CM, Williamson CB, Dolan KE, Finley HJ, Burns CM, Parker EC, Pizano JM, Lipski EA. Probiotics and Disease: A Comprehensive Summary-Part 5, Respiratory Conditions of the Ears, Nose, and Throat. Integr Med (Encinitas). 2017 Jun;16(3):28-40.

  PMID: 30881245 BACKGROUND

• Abreu NA, Nagalingam NA, Song Y, Roediger FC, Pletcher SD, Goldberg AN, Lynch SV. Sinus microbiome diversity depletion and Corynebacterium tuberculostearicum enrichment mediates rhinosinusitis. Sci Transl Med. 2012 Sep 12;4(151):151ra124. doi: 10.1126/scitranslmed.3003783.

  PMID: 22972842 BACKGROUND

• Humphreys GJ, McBain AJ. Antagonistic effects of Streptococcus and Lactobacillus probiotics in pharyngeal biofilms. Lett Appl Microbiol. 2019 Apr;68(4):303-312. doi: 10.1111/lam.13133. Epub 2019 Mar 13.

  PMID: 30776138 BACKGROUND

• Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C. Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients. Crit Care. 2008;12(3):R69. doi: 10.1186/cc6907. Epub 2008 May 20.

  PMID: 18489775 BACKGROUND

• Roos K, Hakansson EG, Holm S. Effect of recolonisation with "interfering" alpha streptococci on recurrences of acute and secretory otitis media in children: randomised placebo controlled trial. BMJ. 2001 Jan 27;322(7280):210-2. doi: 10.1136/bmj.322.7280.210.

  PMID: 11159619 BACKGROUND

• Roos K, Simark-Mattsson C, Grahn Hakansson E, Larsson L, Sandberg T, Ahren C. Can probiotic lactobacilli eradicate persistent carriage of meticillin-resistant Staphylococcus aureus? J Hosp Infect. 2011 May;78(1):77-8. doi: 10.1016/j.jhin.2011.01.010. Epub 2011 Mar 2. No abstract available.

  PMID: 21371778 BACKGROUND

• Bomer K, Brichta A, Baroody F, Boonlayangoor S, Li X, Naclerio RM. A mouse model of acute bacterial rhinosinusitis. Arch Otolaryngol Head Neck Surg. 1998 Nov;124(11):1227-32. doi: 10.1001/archotol.124.11.1227.

  PMID: 9821924 BACKGROUND

• Prince AA, Steiger JD, Khalid AN, Dogrhamji L, Reger C, Eau Claire S, Chiu AG, Kennedy DW, Palmer JN, Cohen NA. Prevalence of biofilm-forming bacteria in chronic rhinosinusitis. Am J Rhinol. 2008 May-Jun;22(3):239-45. doi: 10.2500/ajr.2008.22.3180.

  PMID: 18588755 BACKGROUND

• Rosenfeld RM. Clinical practice guideline on adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3):365-77. doi: 10.1016/j.otohns.2007.07.021.

  PMID: 17765760 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria Lee, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Lee, MD

CONTACT

312.996.6582; vlee39@uic.edu

Anthony I Dick, MBBS, MPH

CONTACT

312-492-5001; adick@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: At the beginning of the study patients will be provided enough study product to complete 2 nasal sinus irrigations/day for a period of 14 days. There will be 1 packet for each nasal irrigation procedure (a total of 28 vials for 2 weeks). The packets will be distributed by the University's Investigational Drug Service (IDS) and will be labeled in a way that neither the patient nor the investigator will know the contents of the packet. Only IDS personnel will have the product/patient code link.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Adult patients of the PI's or co-investigator's with a diagnosis of active CRS and who meet the inclusion and exclusion criteria will be eligible to participate. A total of 60 subjects will be randomize evenly into 2 study groups: 30 patients in the saline group (SAL) and 30 patient in the Lactobacillus sakei group (LAC). Patients will asked to do nasal irrigations 2 times/day for 14 days. Patient history, sinus exams, culture swabs, surveys (SNOT-22) and pain scale will access pre and post treatment results. Patients will be assessed and compared prior to beginning sinus irrigations, the week after irrigations are completed, and 6 weeks after initial assessment.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: February 5, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)