Clinical trial NCT01201434: Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis
Official title: The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
probiotics
pulmonary
infections
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-14
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.

Detailed description: Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.

Eligibility criteria: Inclusion Criteria:

* cystic fibrosis mild to moderate
* at least 3 pulmonary exacerbations requiring antibiotics per year
* Pseudomonas aeruginosa in the sputum
* able to produce sputum

Exclusion Criteria:

* severe pulmonary disease
* less than 3 pulmonary exacerbations per year
* unable to produce sputum

Primary outcomes:
measure: The effect of probiotics on the rate of pulmonary infections compared to placebo
timeFrame: October 2012
Secondary outcomes:
measure: The effect of probiotics on sputum bacteria compared to placebo
timeFrame: October 2012
measure: The effect of probiotics on sputum inflammatory markers
timeFrame: October 2012
measure: The effect of probiotics on gastrointestinal inflammation
timeFrame: October 2012
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center
name: Batia Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center
name: Ori Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiss B, Bujanover Y, Yahav Y, Vilozni D, Fireman E, Efrati O. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol. 2010 Jun;45(6):536-40. doi: 10.1002/ppul.21138.