Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis

Not Applicable

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Bio-25 probiotic

• Registration Number: NCT01201434
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Study Start: 2010-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotics, Treatment, Food Additive	Bio-25 probiotic	-

Primary Outcome Measures

Name	Time	Method
The effect of probiotics on the rate of pulmonary infections compared to placebo	October 2012	The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.

Secondary Outcome Measures

Name	Time	Method
The effect of probiotics on sputum inflammatory markers	October 2012
The effect of probiotics on gastrointestinal inflammation	October 2012
The effect of probiotics on sputum bacteria compared to placebo	October 2012