Effect of Lactobacillus Reuteri in Cystic Fibrosis

Phase 4

Completed

• Conditions: CYSTIC FIBROSIS
• Interventions: Dietary Supplement: Lactobacillus reuteri; Dietary Supplement: placebo

• Registration Number: NCT01737983
• Lead Sponsor: Azienda Policlinico Umberto I

Brief 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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-07-12
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-28
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri (LR) ATCC55730	Lactobacillus reuteri	The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10\^10 colony-forming units) for 6 months
placebo	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

Primary Outcome Measures

Name	Time	Method
efficacy	6 months of observation	Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
Efficacy	6 months of observation	Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.

Secondary Outcome Measures

Name	Time	Method
efficacy	6 months of observation	Evaluate tumor necrosis factor α levels in plasma and induced sputum.

Trial Locations

Locations (1)

Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"; 🇮🇹 Roma, Italy