IRCT2017011732004N1.

Trial name or title	Effect of synbiotic supplementation in comparison with placebo on anthropometric indices, quality of life and clinical outcome in children with cystic fibrosis.
Methods	Trial design: RCT. Trial grouping: parallel group. Randomisation method: table of random numbers.
Participants	Inclusion criteria Children with CF. Aged 5 ‐ 12 years. Exclusion criteria Having other disease including diabetes; cirrhosis; hypo‐albominemia; ventilator dependent respiratory failure.
Interventions	Probiotic 2 synbiotic capsules/day containing: 109 bacteria namely L casei, L ramnosus, L bolgaricus, S thermophilus, B longum and fructo‐oligosaccharides prebiotic. Placebo 2 placebo capsules/day containing corn starch.
Outcomes	Primary outcome measures Anthropocentric measures (before supplementation and every month after supplementation for 6 months). Antibiotic treatment (oral and IV therapy) (before supplementation and 2, 4 and 6 months after supplementation). Diarrhea (before supplementation and every month after supplementation for 6 months). Hospitalization (before supplementation and every month after supplementation for 6 months). Quality of life (before supplementation and every month after supplementation for 6 months). Secondary outcome measures Serum total antioxidant (before and after 6 months of supplementation).
Starting date	14 February 2017.
Contact information	Assistant Professor Zeinab Nikniaz Liver and Gastrointestinal Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Islamic Republic of Iran. Phone: +98 41 3336 7473. Email address: nikniazz@tbzmed.ac.ir.
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