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.

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.

Study Overview

• Status: Completed
• Conditions: CYSTIC FIBROSIS
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus reuteri (LR) ATCC55730; The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10^10 colony-forming units) for 6 months	Dietary supplement: Lactobacillus reuteri; Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.; Other Names: (LR) ATCC55730
Placebo Comparator: placebo; The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation for 6 months During the test period, patients were not allowed to consume any other product that contained probiotics or prebiotics	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Efficacy	Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.	6 months of observation
efficacy	Evaluate number of gastrointestinal and upper respiratory tract infections.	6 months of observation
efficacy	Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.	6 months of observation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy	Evaluate change in qualitative sputum bacteria;	6 months of observation
efficacy	Evaluate change in fecal calprotectin concentration.	6 months of observation
efficacy	Evaluate interleukin 8 levels in plasma and induced sputum.	6 months of observation
efficacy	Evaluate change in quantitative sputum bacteria;	6 months of observation
efficacy	Evaluate tumor necrosis factor α levels in plasma and induced sputum.	6 months of observation

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I

Publications and helpful links

General Publications

• Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 28, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: probiotics; cystic fibrosis; Lactobacillus reuteri
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: lactobacillus reuteri in fc