Cystic Fibrosis Patients MedDRA version: 9.1 Level: SOC Classification code 10017947
Conditions
Interventions
Pharmaceutical Form: Modified-release capsule, soft
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: equal
Concentration n
Sponsors
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypotheses that interventions to restore intestinal microflora, such as probiotic administration, may decrease intestinal and extraintestinal inflammation, ultimately improving CF quality of life and clinical course.;Secondary Objective: To test the hypotheses that: - Intestinal microflora is also modified and is characterized by bacterial species that are detected selectively or more frequently in CF, whereas other species that are detected in non CF subjects are not found in CF. - Intestinal inflammation is a very frequent feature of CF, possibly as a consequence of changes in intestinal microflora. - Intestinal inflammation contributes to extraintestinal inflammation, including the respiratory tract. - intestinal microenvironment is modified in cystic fibrosis (CF).;Primary end point(s): - Incidence and severity of intestinal inflammation, as measured by fecal calprotectin concentration and by rectal nitric oxide concentration. -Quality of life (assessed by the revised Italian version of a questionnaire assessing Quality of Life (CFQoL). -Composition of colonic microflora before and after LGG administration and antibiotic therapy -Incidence, duration and severity of pulmonary exacerbations, as judged by the number of episodes and number of days free of intravenous antibiotic treatment. -Pulmonary function, as measured by FEV1 and FVC. -Hospital admissions. -Incidence, duration and severity of abdominal pain episodes. -Nutritional status -Systemic inflammation. | — |
Countries
Italy
Outcome results
None listed