Probiotics in Cystic Fibrosis

Federico II University

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Lactobacillus rhamnosus GG; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01956916

CF001

2009-011289-27 (EudraCT Number)

Details and patient eligibility

About

Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators have previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The investigators aim to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The investigators aim is to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.

Enrollment: 110 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Boys and girls between 2 and 16 years of age
3. Clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks
4. Pancreatic insufficiency
5. Basal Forced Expiratory Volume 1 second above 50% of predicted value

Exclusion criteria

1. Colonization of respiratory tract with Burkholderia cepacia spp.
2. Steroid therapy within one month before enrolment
3. Pregnancy and fertile women taking oral contraceptives
4. Parenteral or oral antibiotics therapy within 2 weeks before enrolment
5. Regular assumption of probiotics
6. Regular assumption of azythromycin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

Capsules containing lyophilized 6x10\^9 Colony Forming Units (CFU)/die of Lactobacillus rhamnosus GG (LGG)

Treatment:

Dietary Supplement: Lactobacillus rhamnosus GG

Placebo

Placebo Comparator group

Description:

Capsules containing maltodextrin

Treatment:

Dietary Supplement: placebo