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Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Lactobacillus sakei proBio65

Isotonic Saline Solution

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 weeks 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.

Exclusion Criteria:

Male and female patients under 18 years of age.
Patients who have not been diagnosed with CRS or 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 weeks prior to enrollment with patent sinuses deemed unsuitable for trial on investigator's discretion.
Patients unwilling to follow study related procedures for the duration of the study.
Patients who are unable to independently understand the study purpose and procedures and who are not willing to sign the study informed consent document.
Patients who are taking topical antibiotic irrigations and state they 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, immunocompromised or systemic disease (e.g. granulomatosis polyangiitis, cystic fibrosis).
Patients who have severe or emergent complications from CRS or presence of a sinus tumor.
Female patients who are pregnant or breastfeeding.
Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Saline Nasal Irrigation (Control)

Lactobacillus sakei nasal irrigation

Arm Description

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 vial 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.

Patients will perform nasal irrigation with 1 gram of product 2 times/day for 14 days. Each gram of product contains 1×10(9) CFU L. Sakei that will be dissolved in 240 ml water using a 240ml NeilMed sinus rinse bottle. A blinded vial 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sinus microbiota

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.

Full Information

NCT ID

NCT05427695

First Posted

June 10, 2022

Last Updated

April 13, 2023

Sponsor

University of Illinois at Chicago

Collaborators

Cures Within Reach

1. Study Identification

Unique Protocol Identification Number

NCT05427695

Brief Title

Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

Collaborators

Cures Within Reach

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this non-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.

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 (1×10(9) CFU L. Sakei nasal irrigation in 240 ml water/irrigation) or Isotonic saline solution in 240 ml of water for 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, CT scan assessments using Lund-MacKay CT staging system, culture swab of the sinuses (bacterial burden and number of taxa, SNOT-22 survey, and a visual analog scale to record pain scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

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 vial for each nasal irrigation procedure (a total of 28 vials for 2 weeks). The vials will be prepared by the University's Investigational Drug Service and will be labeled in a way that neither the patient nor the investigator will know the contents of the vial. what product with a study code for each scheduled sinus irrigation. Only IDS personnel will have the product/patient code.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Saline Nasal Irrigation (Control)

Arm Type

Active Comparator

Arm Description

Arm Title

Lactobacillus sakei nasal irrigation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lactobacillus sakei proBio65

Other Intervention Name(s)

Lanto Sinus Probiotic Powder

Intervention Description

Lanto Sinus probiotic Lactobacillus sakei is a currently available over the counter supplement from the common source kimchi and produced in South Korea. The product contains 17 billion total CFU of Lactobacillus sakei/gram at the time of manufacture. Lanto Sinus is produced using Good Manufacturing Practice standards. The probiotic is packaged as a powder in PE plastic bottles with 15 grams of product in each bottle. IDS will aliquot 1 gram of product/unlabeled vial, 28 vials/patient. Patients will be instructed to mix 1 vail with 240 mls of distilled water.

Intervention Type

Other

Intervention Name(s)

Isotonic Saline Solution

Other Intervention Name(s)

NeilMed Isotonic Sinus Rinse

Intervention Description

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 vial (containing NeilMed® premixed buffered salt powder) with lukewarm distilled or boiled water in 240mL NeilMed® sinus rinse bottle.

Primary Outcome Measure Information:

Title

Sinonasal Outcome Test-22 (SNOT-22)

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Sinus microbiota

Description

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Lund-Kennedy Score

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 weeks 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. Exclusion Criteria: Male and female patients under 18 years of age. Patients who have not been diagnosed with CRS or 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 weeks prior to enrollment with patent sinuses deemed unsuitable for trial on investigator's discretion. Patients unwilling to follow study related procedures for the duration of the study. Patients who are unable to independently understand the study purpose and procedures and who are not willing to sign the study informed consent document. Patients who are taking topical antibiotic irrigations and state they 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, immunocompromised or systemic disease (e.g. granulomatosis polyangiitis, cystic fibrosis). Patients who have severe or emergent complications from CRS or presence of a sinus tumor. Female patients who are pregnant or breastfeeding. Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Victoria Lee, MD

Phone

312.996.6582

vlee39@uic.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ginevra Ciavarella, Ph.D.

Phone

312.996.6582

gciava1@uic.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Lee, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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27935259

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Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

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