Probiotics in Cystic Fibrosis

Phase 3

Completed

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG; Dietary Supplement: placebo

• Registration Number: NCT01956916
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Lactobacillus rhamnosus GG	Capsules containing lyophilized 6x10\^9 Colony Forming Units (CFU)/die of Lactobacillus rhamnosus GG (LGG)
Placebo	placebo	Capsules containing maltodextrin

Primary Outcome Measures

Name	Time	Method
Change of intestinal inflammation from baseline to 12 months of treatment	every six months up to 18 months	Assessment of intestinal inflammation is performed four times. First time at enrollment, second time at the end of six months of observation. Third time after six months of treatment and fourth time after 12 months of treatment.
Change in the incidence of pulmonary exacerbations from baseline to 12 months of treatment	every six months up to 18 months	The incidence of pulmonary exacerbation is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Change in the incidence of hospital admission from baseline to 12 months of treatment	every six month up to 18 months	The incidence of hospital admission is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment
change in pulmonary function from baseline to 12 months of treatment (measured by Forced Expiratory Volume 1 sec (FEV1))	every six months up to 18 months	Assessment of pulmonary function is performed four times. First time at enrollment, second time at the end of six months of observation. Third time after six months of treatment and fourth time after 12 months of treatment.

Trial Locations

Locations (5)

Università degli studi di Napoli "Federico II"; 🇮🇹 Napoli, Italy

Ospedale "Bambino Gesù" - Roma; 🇮🇹 Rome, Italy

Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena; 🇮🇹 Milano, Italy

- Department of Paediatric Medicine, CF Center, "A. Meyer" Children's Hospital; 🇮🇹 Florence, Italy

Dipartimento di Pediatria - Università Di Messina; 🇮🇹 Messina, Italy