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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotics, Treatment, Food Additive

Group Type EXPERIMENTAL

Bio-25 probiotic

Intervention Type DIETARY_SUPPLEMENT

2 tablets per day for 6 months

Interventions

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Bio-25 probiotic

2 tablets per day for 6 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bio-25 by Supherb

Eligibility Criteria

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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