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Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis. This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 11 ratio to receive either budesonide 4 mg suppository o