Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07460934
Eligibility Criteria:
Inclusion Criteria:
* age over 12 years
* signed informed consent
* patients with newly diagnosed CRS without nasal polyps (meeting the criteria for the definition of CRS according to EPOS)
* patients without anatomical abnormalities causing nasal obstruction (nasal septal deformity, nasal turbinate hyperplasia, tumours, craniofacial deformities)
* patients able and willing to complete the questionnaires, undergo rhinoendoscopic examination, upper aerodigestive tract swabs and follow-up outpatient examinations
Exclusion Criteria:
* refused informed consent
* inability/unwillingness to complete the questionnaire, undergo rhinoendoscopic examination, upper aerodigestive tract swabs, follow-up outpatient examinations
* inability/unwillingness to use the product in accordance with the research protocol and compliance \< 75%
* patients with protracted rhinosinusitis, exacerbations rhinosinusitis with the presence of an asymptomatic period
* patients with CRS during conservative treatment
* patients with CRS after previous surgical treatment
* patients with grade 3 nasal polyps
* patients with adenoid vegetations/persistent pharyngeal tonsils (especially if children are included in the study)
* patients with CRS with anatomical abnormalities causing nasal obstruction (septal deformity, turbinate hyperplasia, tumors, craniofacial abnormalities)
* patients with significant immunodeficiency
* patients with mucociliary transport disorders (e.g. cystic fibrosis, primary ciliary dyskinesia)
* patients taking other immunomodulating preparations regularly and for a long time (e.g. beta-glucans, Preventan, vitamins C and D, probiotics, Echinacea, bacterial lysates, etc.)
* pregnant and breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT07460934
Study Brief:
Protocol Section:
NCT07460934