Effects of Probiotics on Quality of Life in Children with Cystic Fibrosis; A Randomized Controlled Trial

Objective: Patients with cystic fibrosis (CF) usually have abnormal intestinal microbiota and dysregulated immune mediators due to massive exposure to antibiotics. Probiotics as immunomodulatory and anti-inflammatory substances are considered to improve both clinical and biochemical intestinal and pulmonary function in CF patients. We decided to investigate the effects of probiotics on quality of life and pulmonary exacerbations in children with cystic fibrosis. Methods: In a prospective, randomized, controlled clinical trial, 37 CF patients (2-12 years old) were randomly divided into two groups. 20 patients of probiotic group took probiotics (2x10(9)CFU/d) for one month while 17 patients of control group took placebo capsules. Quality of life was determined using PedsQL (TM) 4.0 questionnaire at the beginning, then three and six months after completing the treatment period. Rate of pulmonary exacerbation in probiotic group patients was also evaluated during three months after intervention and compared to the same three months of the previous year. Results were analyzed using SPSS (11.5). P<0.05 was considered statistically significant. Findings: Significant improvement was observed in the mean total score of parent reported quality of life among probiotic group patients in comparison with placebo group at 3rd month (P=0.01), but this was not significant at 6th month of probiotic treatment. Rate of pulmonary exacerbation was significantly reduced among probiotic group (P<0.01). Conclusion: Probiotics are considered as useful nutritional supplements on reducing number of pulmonary exacerbations and improving quality of life in patients with cystic fibrosis. Effects of probiotics seem to be temporary and probably continuous ingestion might have more stable improving effects on quality of life.