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

Sheba Medical Center

Status: Terminated

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Bio-25 probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01201434

SHEBA-10-7702-BW-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 5 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 1 patient group

Probiotics, Treatment, Food Additive

Experimental group

Treatment:

Dietary Supplement: Bio-25 probiotic