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. 2020 Jan 22;2020(1):CD012949. doi: 10.1002/14651858.CD012949.pub2

IRCT201201258778N3.

Methods Double‐blind RCT.
Design: parallel.
Duration: 4 weeks.
Location: single centre (Children Medical Center, Tehran).
Participants Inclusion criteria: children with CF aged between 4 and 18 years of age; either gender; pancreatic insufficient ; no NSAIDs for 2 weeks prior to enrolment.
Exclusion criteria: younger than 4 years of age; pancreatic sufficient; used NSAIDs during 2 weeks prior to enrolment.
Target sample size: 25.
Interventions Intervention: protexin 2 sachet per day which can be mixed with yoghurt.
Placebo: maltodextrin 2 sachet per day which can be mixed in yoghurt.
Outcomes Change in fecal calprotectin at 1 month.
Notes Funding source: drug and placebo send by manufacturer free of charge and no payment to the Tehran Medical University for running the trial.
Contact: A/Professor Dr Farzaneh Motamed, Pediatric Gasteroentrologist, Children Medical Center, 62 Gharib St, 14194 Tehran, Iran (fmotamed@sina.tums.ac.ir).