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Effect of Lactobacillus Reuteri in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01737983
First received: July 12, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
CYSTIC FIBROSIS
 Dietary Supplement: Lactobacillus reuteri
Dietary Supplement: placebo
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.

  • Efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate number of gastrointestinal and upper respiratory tract infections.

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.


Secondary Outcome Measures:
  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate change in qualitative sputum bacteria;

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate change in fecal calprotectin concentration.

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate interleukin 8 levels in plasma and induced sputum.

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate change in quantitative sputum bacteria;

  • efficacy [ Time Frame: 6 months of observation ] [ Designated as safety issue: No ]
    Evaluate tumor necrosis factor α levels in plasma and induced sputum.


Enrollment: 61
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: (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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   6 Years to 42 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737983

Locations
Italy
Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"
Roma, Italy, 00161
Sponsors and Collaborators
Azienda Policlinico Umberto I
  More Information

No publications provided

Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01737983     History of Changes
Other Study ID Numbers: lactobacillus reuteri in fc
Study First Received: July 12, 2012
Last Updated: November 28, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Policlinico Umberto I:
cystic fibrosis
probiotics
Lactobacillus reuteri

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on June 18, 2013