Background: Considering the role of leukotrienes in inflammatory pathways, and owing to the anti-leukotrienes effect of montelukast, in the present clinical trial, we aimed to assess the effect of montelukast on remission maintenance in patients with ulcerative colitis (UC).
Methods: In the present double-blind randomized controlled clinical trial, 222 volunteer UC patients on high-dose corticosteroid and montelukast were recruited. The patients received 10 mg of montelukast (98 patients) or placebo (124 patients) for 22 weeks.