Effect of Lactobacillus Reuteri in Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT01737983|
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|CYSTIC FIBROSIS||Dietary Supplement: Lactobacillus reuteri Dietary Supplement: placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 2009|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
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
- Efficacy [ Time Frame: 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 [ Time Frame: 6 months of observation ]Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
- efficacy [ Time Frame: 6 months of observation ]Evaluate number of gastrointestinal and upper respiratory tract infections.
- efficacy [ Time Frame: 6 months of observation ]Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
- efficacy [ Time Frame: 6 months of observation ]Evaluate change in qualitative sputum bacteria;
- efficacy [ Time Frame: 6 months of observation ]Evaluate change in fecal calprotectin concentration.
- efficacy [ Time Frame: 6 months of observation ]Evaluate interleukin 8 levels in plasma and induced sputum.
- efficacy [ Time Frame: 6 months of observation ]Evaluate change in quantitative sputum bacteria;
- efficacy [ Time Frame: 6 months of observation ]Evaluate tumor necrosis factor α levels in plasma and induced sputum.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737983
|Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"|
|Roma, Italy, 00161|