A Phase 4 interventional study of Lactobacillus reuteri and placebo in CYSTIC FIBROSIS, sponsored by Azienda Policlinico Umberto I. Completed at 1 site in Italy. Open to participants aged 6 Years to 42 Years. Per ClinicalTrials.gov, last updated 2012-11-30.
Sponsored by Azienda Policlinico Umberto I · Phase 4, Interventional, and Treatment
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 61 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Azienda Policlinico Umberto I is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10\^10 colony-forming units) for 6 months
Dietary Supplement: Lactobacillus reuteri
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
Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.
Also known as: (LR) ATCC55730
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
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
Efficacy
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
Time frame: 6 months of observation
efficacy
Evaluate number of gastrointestinal and upper respiratory tract infections.
Time frame: 6 months of observation
efficacy
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
Time frame: 6 months of observation
efficacy
Evaluate change in qualitative sputum bacteria;
Time frame: 6 months of observation
efficacy
Evaluate change in fecal calprotectin concentration.
Time frame: 6 months of observation
efficacy
Evaluate interleukin 8 levels in plasma and induced sputum.
Time frame: 6 months of observation
efficacy
Evaluate change in quantitative sputum bacteria;
Time frame: 6 months of observation
efficacy
Evaluate tumor necrosis factor α levels in plasma and induced sputum.
Time frame: 6 months of observation
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Azienda Policlinico Umberto I