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New treatment option for Chronic Rhinosinusitis (Diagnosis)
Official title Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
ClinicalTrials.gov ID: NCT05427695
What this study is testing
What is Lactobacillus sakei proBio65?
Lactobacillus sakei proBio65 is an investigational medicine, given as a twice-daily treatment applied to the skin, being studied as a potential treatment for chronic rhinosinusitis (diagnosis).
Also referred to as Lanto Sinus Probiotic Powder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients that have undergone functional endoscopic sinus surgery \> 12 months prior to enrollment as documented in the patients electronic medical...
- 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.
You likely can't join 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...
- 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...
- Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- Patients who are taking oral corticosteroids or who have taken oral antibiotics in the previous 2 weeks or on oral corticosteroids.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.