Effect of Lactobacillus Reuteri in Cystic Fibrosis
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
Zuletzt überprüft: | 10/31/2012 |
Zuerst eingereicht: | 07/11/2012 |
Geschätzte Einschreibung eingereicht: | 11/27/2012 |
Zuerst veröffentlicht: | 11/29/2012 |
Letztes eingereichtes Update: | 11/27/2012 |
Letztes Update veröffentlicht: | 11/29/2012 |
Tatsächliches Startdatum der Studie: | 04/30/2009 |
Geschätztes primäres Abschlussdatum: | 06/30/2011 |
Voraussichtliches Abschlussdatum der Studie: | 06/30/2011 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: Lactobacillus reuteri (LR) ATCC55730
Dietary Supplement: placebo
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
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 (LR) ATCC55730 Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months. |
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 |
Zulassungskriterien
Altersberechtigt für das Studium | 6 Years Zu 6 Years |
Studienberechtigte Geschlechter | All |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | 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. |
Ergebnis
Primäre Ergebnismaße
1. Efficacy [6 months of observation]
2. Efficacy [6 months of observation]
3. efficacy [6 months of observation]
4. efficacy [6 months of observation]
Sekundäre Ergebnismaße
1. efficacy [6 months of observation]
2. efficacy [6 months of observation]
3. efficacy [6 months of observation]
4. efficacy [6 months of observation]
5. efficacy [6 months of observation]