title: Effects of probiotics on quality of life in children with cystic fibrosis; a randomized controlled trial.
abstract: 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 (2×10(9)CFU/d) for one month while 17 patients of control group took placebo capsules. Quality of life was determined using PedsQL™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.
  
  
  RESULTS
  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 3(rd) month (P=0.01), but this was not significant at 6(th) month of probiotic treatment. Rate of pulmonary exacerbation was significantly reduced among probiotic group (P<0.01).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatric Gastroenterology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Seyed-Ali
authors.initials: SA
authors.lastname: Jafari
authors.affiliation: Cystic Fibrosis Clinic, Dr. Sheikh Pediatric Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Atieh
authors.initials: A
authors.lastname: Mehdizadeh-Hakkak
authors.affiliation: Nuclear Medicine Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Hamid-Reza
authors.initials: HR
authors.lastname: Kianifar
authors.affiliation: Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Paria
authors.initials: P
authors.lastname: Hebrani
authors.affiliation: Department of Pediatric Immunology and Allergy, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Hamid
authors.initials: H
authors.lastname: Ahanchian
authors.affiliation: Department of Pediatric Gastroenterology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Elaheh
authors.initials: E
authors.lastname: Abbasnejad
keywords: Cystic Fibrosis; Probiotics; Pulmonary Exacerbation; Quality of Life