Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, probiotics, pulmonary, infections
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.
Interventions
DIETARY_SUPPLEMENTBio-25 probiotic
2 tablets per day for 6 months
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The effect of probiotics on sputum bacteria compared to placebo | October 2012 |
| The effect of probiotics on sputum inflammatory markers | October 2012 |
| The effect of probiotics on gastrointestinal inflammation | October 2012 |
Outcome results
None listed