infants with cystic fibrosis MedDRA version: 9.1 Level: SOC Classification code 10017947 MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: equal
Concentration number: 2000000000
Sponsors
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants with CF diagnosed through screening and confirmed with sweat test and molecular analysis Both male and fermale Pancreatic insufficiency 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
Exclusion criteria: Treatment with oral steroids within 1 month before the start of treatment Antibiotic therapy (both oral and/or parenteral) within 15 days before the enrolment Probiotic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that: 1. Intestinal microenvironment is modified in CF likely as a consequence of CFTR mutations. 2. A long term therapy with live biological supplements in infants diagnosed for CF through newborn screening may have an effect on intestinal and extraintestinal inflammation modifying the natural history of CF.;Secondary Objective: A reduction or improvement, following probiotics use, of: - nutritional status - number of pulmonary exacerbations - number of hospital admissions - number of antibiotic courses - time of colonization with Pseudomonas Aeruginosa;Primary end point(s): Evaluation of intestinal microflora and intestinal inflammation in infants with CF diagnosed through neonatal screening Evaluation of changes in intestinal microflora and inflammation using probiotics | — |
Countries
Italy
Outcome results
None listed