CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial.

Study design (if review, criteria of inclusion for studies)

Double-blind randomized clinical trial


40 CF children


Children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for 6 months.

Outcome measures

The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires.

Main results

Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34 ± 17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p > 0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores.

Authors' conclusions

According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion.

Keywords: Child; Probiotics; Supplementation; Oral; Immunoregulatory; pharmacological_intervention; Adult; Lactobacillus; Synbiotic;