Effect of Lactobacillus Reuteri in Cystic Fibrosis

CYSTIC FIBROSIS Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737983
• Other study ID #: lactobacillus reuteri in fc
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2012
• Last updated: November 28, 2012
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2012
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 42 Years

Eligibility

Inclusion Criteria:

• Forced expiratory volume in the 1st second (FEV1) > 70%.

• No inhaled or systemic steroids.

• No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.

• No serious organ involvement.

Exclusion Criteria:

• History of pulmonary exacerbation or upper respiratory infection in the previous two months.

• Changes in medications in the past two months.

• History of hemoptysis in the past two months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CYSTIC FIBROSIS
• Fibrosis
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Lactobacillus reuteri
Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.
• 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

Locations

Country	Name	City	State
Italy	Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.	6 months of observation	No
Primary	Efficacy	Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.	6 months of observation	No
Primary	efficacy	Evaluate number of gastrointestinal and upper respiratory tract infections.	6 months of observation	No
Primary	efficacy	Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.	6 months of observation	No
Secondary	efficacy	Evaluate change in qualitative sputum bacteria;	6 months of observation	No
Secondary	efficacy	Evaluate change in fecal calprotectin concentration.	6 months of observation	No
Secondary	efficacy	Evaluate interleukin 8 levels in plasma and induced sputum.	6 months of observation	No
Secondary	efficacy	Evaluate change in quantitative sputum bacteria;	6 months of observation	No
Secondary	efficacy	Evaluate tumor necrosis factor a levels in plasma and induced sputum.	6 months of observation	No