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:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT01961661
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CF documented by sweat chloride test over 60 mmol/L and confirmed by genotype analysis with the presence of F508del/F508del or F508del/other;
* Boys and girls between 2 and 16 years of age;
* Clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks;
* Pancreatic insufficiency;
* Basal Forced expiratory volume 1 second (FEV1) above 50% of predicted value.
Exclusion Criteria
* Colonization of respiratory tract with Burkholderia cepacia spp.;
* Steroid therapy within one month before enrolment;
* Pregnancy and fertile women taking oral contraceptives;
* Parenteral or oral antibiotics therapy within 2 weeks before enrolment;
* Regular assumption of probiotics;
* Regular assumption of azythromycin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01961661
Study Brief:
Protocol Section:
NCT01961661