Modulation of intestinal and extraintestinal inflammation in infants with Cystic Fibrosis by early modification of intestinal microflora - Role of intestinal microflora in infants with Cystic Fibrosis

Conditions: infants with cystic fibrosis
MedDRA version: 9.1Level: SOCClassification code 10017947
MedDRA version: 9.1Level: SOCClassification code 10038738

Registration Number: EUCTR2009-015875-28-IT

Lead Sponsor: IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the hypothesis that: <br>1.Intestinal microenvironment is modified in CF likely as a consequence of CFTR mutations. <br>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:<br>- nutritional status <br>- number of pulmonary exacerbations <br>- number of hospital admissions <br>- number of antibiotic courses <br>- 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 <br>Evaluation of changes in intestinal microflora and inflammation using probiotics

Secondary Outcome Measures