Clinical trial NCT01737983: Effect of Lactobacillus Reuteri in Cystic Fibrosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CYSTIC FIBROSIS
Keywords: cystic fibrosis
probiotics
Lactobacillus reuteri
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy
timeFrame: 6 months of observation
measure: Efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
Secondary outcomes:
measure: efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
measure: efficacy
timeFrame: 6 months of observation
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"
Study officials:
References:
citation: Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.