Background: Curcumin in an active phytochemical substance, used as part of the human diet,
that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple
experimental models of colitis including a positive effect on maintenance of remission in
adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as
complementary medication in induction and maintenance therapy in pediatric patients with mild
to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study.
Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who
are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or
corticosteroids induction treatment. Main outcome measures: Disease activity defined by the
Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary
outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin
and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version
21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate
associations between primary outcomes and categorical variables. Associations of continues
variables with primary outcome measures will be examined using ANOVA with repeated measures.
P-values <0.05 will be considered significant.