Probiotics in Cystic Fibrosis - ND

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2009-011289-27-IT
• Date of registration: 27/04/2009
• Prospective Registration: No
• Primary sponsor: UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
• Public title: Probiotics in Cystic Fibrosis - ND
• Scientific title: Probiotics in Cystic Fibrosis - ND
• Date of first enrolment: 22/04/2009
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011289-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis Patients
MedDRA version: 9.1 Level: SOC Classification code 10017947

Intervention(s)

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 number: 20000000000-
Pharmaceutical form of the placebo: Modified-release capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

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).

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.

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.

Secondary ID(s)

CF001