Objective: Probiotics were reported to reduce intestinal inflammation and pulmonary exacerbation rate in cystic fibrosis (CF) patients. We intended to determine the effect of a mixed probiotic preparation on pulmonary exacerbations, inflammatory characteristics of sputum and stool in CF patients.
Design: A prospective placebo-controlled cross-over study of patients with mild-moderate lung disease and Pseudomonas aeruginosa colonization, treated each blindly with probiotics for 6 months and placebo for 6 months. Pulmonary function tests (PFT`s), sputum cultures with semiquatitative bacterial analysis, sputum neutrophil count and cytokine levels, and fecal calprotectin were followed.
Results: We intended to include 30 patients. The 7th patient developed a severe allergic reaction related to the study probiotic and the study was discontinued. Six patients, age 19-37 years (4 males), completed the study. No difference was found in PFT`s, body weight and hospitalization rate between probiotics and placebo treatment. In one patient sputum Pseudomonas aeruginosa disappeared after probiotic and re-appeared at the end of placebo treatment. No significant change was found in sputum levels of IL-6, IL-8, IL-1β during both treatments. Fecal calprotectin was high at baseline in 5 patients (>250 mcg/gr stool), with no change during probiotics or placebo treatment.
Conclusions: The mixed probiotic preparation used here had no effect on pulmonary exacerbations, sputum inflammatory markers and fecal calprotectin compared to placebo. Fecal calprotectin is high in most of CF patients at baseline, reflecting a constant inflammatory state. Despite the small number patients, the placebo control and cross-over design make the results of this study worth further investigation.