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Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

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ClinicalTrials.gov Identifier: NCT05427695
Recruitment Status : Not yet recruiting
First Posted : June 22, 2022
Last Update Posted : May 8, 2024
Sponsor:
Collaborator:
Cures Within Reach
Information provided by (Responsible Party):
Victoria S. Lee, University of Illinois at Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Lactobacillus sakei proBio65 Other: Isotonic Saline Solution Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Topical Probiotic Sinus Irrigations for the Treatment of Chronic Rhinosinusitis: a Double Blinded Randomized Controlled Trial
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : July 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Lanto Sinus Probiotic Powder


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427695


Contacts
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Contact: Victoria Lee, MD 312.996.6582 vlee39@uic.edu
Contact: Ginevra Ciavarella, Ph.D. 312.996.6582 gciava1@uic.edu

Sponsors and Collaborators
University of Illinois at Chicago
Cures Within Reach
Investigators
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Principal Investigator: Victoria Lee, MD University of Illinois at Chicago
More Information
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Publications:
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.

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Responsible Party: Victoria S. Lee, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05427695    
Other Study ID Numbers: 2021-1205
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rhinosinusitis
Rhinitis
Respiratory Tract Infections
Infections
Sinusitis
 Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases