Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: Cures Within Reach

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 weeks 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. Male and female patients under 18 years of age.

2. 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.

3. Patients that have undergone functional endoscopic sinus surgery < 12 weeks prior to enrollment with patent sinuses deemed unsuitable for trial on investigator's discretion.

4. Patients unwilling to follow study related procedures for the duration of the study.

5. Patients who are unable to independently understand the study purpose and procedures and who are not willing to sign the study informed consent document.

6. Patients who are taking topical antibiotic irrigations and state they are unwilling to stop them.

7. Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions.

8. Patients who have a terminal illness, immunocompromised or systemic disease (e.g. granulomatosis polyangiitis, cystic fibrosis).

9. Patients who have severe or emergent complications from CRS or presence of a sinus tumor.

10. Female patients who are pregnant or breastfeeding.

11. Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.