search
Back to results

Effect of Lactobacillus Reuteri in Cystic Fibrosis

Primary Purpose

CYSTIC FIBROSIS

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus reuteri
placebo
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CYSTIC FIBROSIS focused on measuring cystic fibrosis, probiotics, Lactobacillus reuteri

Eligibility Criteria

6 Years - 42 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus reuteri (LR) ATCC55730

placebo

Arm Description

The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10^10 colony-forming units) for 6 months

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

Outcomes

Primary Outcome Measures

Efficacy
Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
Efficacy
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
efficacy
Evaluate number of gastrointestinal and upper respiratory tract infections.
efficacy
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.

Secondary Outcome Measures

efficacy
Evaluate change in qualitative sputum bacteria;
efficacy
Evaluate change in fecal calprotectin concentration.
efficacy
Evaluate interleukin 8 levels in plasma and induced sputum.
efficacy
Evaluate change in quantitative sputum bacteria;
efficacy
Evaluate tumor necrosis factor α levels in plasma and induced sputum.

Full Information

First Posted
July 12, 2012
Last Updated
November 28, 2012
Sponsor
Azienda Policlinico Umberto I
search

1. Study Identification

Unique Protocol Identification Number
NCT01737983
Brief Title
Effect of Lactobacillus Reuteri in Cystic Fibrosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CYSTIC FIBROSIS
Keywords
cystic fibrosis, probiotics, Lactobacillus reuteri

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri (LR) ATCC55730
Arm Type
Experimental
Arm Description
The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10^10 colony-forming units) for 6 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Other Intervention Name(s)
(LR) ATCC55730
Intervention Description
Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy
Description
Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
Time Frame
6 months of observation
Title
Efficacy
Description
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate number of gastrointestinal and upper respiratory tract infections.
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
Time Frame
6 months of observation
Secondary Outcome Measure Information:
Title
efficacy
Description
Evaluate change in qualitative sputum bacteria;
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate change in fecal calprotectin concentration.
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate interleukin 8 levels in plasma and induced sputum.
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate change in quantitative sputum bacteria;
Time Frame
6 months of observation
Title
efficacy
Description
Evaluate tumor necrosis factor α levels in plasma and induced sputum.
Time Frame
6 months of observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"
City
Roma
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24121143
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Lactobacillus Reuteri in Cystic Fibrosis

We'll reach out to this number within 24 hrs