NCT01737983

Effect of Lactobacillus Reuteri in Cystic Fibrosis

Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 6 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

Detailed description

The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics. Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present. Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.

Conditions

• CYSTIC FIBROSIS

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri	Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.
DIETARY_SUPPLEMENT	placebo	The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2012-11-30
• Last updated: 2012-11-30

Locations

1 site across 1 country: Italy