Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
ConditionChronic Rhinosinusitis (Diagnosis)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lactobacillus sakei proBio65
- Isotonic Saline Solution
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Illinois at Chicago
Lead sponsor
Cures Within Reach
Collaborator
Source ClinicalTrials.gov