Probiotics in Cystic Fibrosis - ND

• Conditions: Cystic Fibrosis Patients; MedDRA version: 9.1Level: SOCClassification code 10017947

• Registration Number: EUCTR2009-011289-27-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-27
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- a confirmed 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; - in stable clinical condition at enrolment; - with pancreatic insufficiency; - with basal FEV1 above 50% of predicted value
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnancy and fertile women taking oral contraceptives; - pancreatic sufficiency; - oral steroid therapy within one month before enrolment; - parenteral or oral antibiotics therapy within 2 weeks before enrolment ; - regular assumption of probiotics; - regular use of azythromicin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified