Effect of Lactobacillus Reuteri in Cystic Fibrosis

Sponsor

Azienda Policlinico Umberto I (Other)

Overall Status

Completed

CT.gov ID

NCT01737983

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
CYSTIC FIBROSIS	Dietary Supplement: Lactobacillus reuteri Dietary Supplement: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy [6 months of observation]
Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
Efficacy [6 months of observation]
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
efficacy [6 months of observation]
Evaluate number of gastrointestinal and upper respiratory tract infections.
efficacy [6 months of observation]
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.

Secondary Outcome Measures

efficacy [6 months of observation]
Evaluate change in qualitative sputum bacteria;
efficacy [6 months of observation]
Evaluate change in fecal calprotectin concentration.
efficacy [6 months of observation]
Evaluate interleukin 8 levels in plasma and induced sputum.
efficacy [6 months of observation]
Evaluate change in quantitative sputum bacteria;
efficacy [6 months of observation]
Evaluate tumor necrosis factor α levels in plasma and induced sputum.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 42 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"	Roma		Italy	00161

Sponsors and Collaborators

Azienda Policlinico Umberto I

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giovanni Di Nardo, MD, Azienda Policlinico Umberto I

ClinicalTrials.gov Identifier:

NCT01737983

Other Study ID Numbers:

lactobacillus reuteri in fc

First Posted:

Nov 30, 2012

Last Update Posted:

Nov 30, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Giovanni Di Nardo, MD, Azienda Policlinico Umberto I

cystic fibrosis

probiotics

Lactobacillus reuteri

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Nov 30, 2012