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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01737983
Enrollment
61
Registered
2012-11-30
Start date
2009-05-31
Completion date
2011-07-31
Last updated
2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYSTIC FIBROSIS

Keywords

cystic fibrosis, probiotics, Lactobacillus reuteri

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus reuteri

Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.

DIETARY_SUPPLEMENTplacebo

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

Sponsors

Azienda Policlinico Umberto I
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 42 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy6 months of observationEvaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
efficacy6 months of observationEvaluate number of gastrointestinal and upper respiratory tract infections.

Secondary

MeasureTime frameDescription
efficacy6 months of observationEvaluate change in qualitative sputum bacteria;

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026