ADDITIVE EFFECT OF PROBIOTICS ON 5-AMINOSALICYLIC ACID THERAPY IN PATIENT WITH ULCERATIVE COLITIS

Abstract BACKGROUND AND AIMS In patients with ulcerative colitis (UC), Escherichia coli Nissle 1917 (EcN) is equivalent to mesalazine for preventing disease relapse; however, data regarding the ability of EcN to increase health-related quality of life or induce remission, compared with placebo, remain scarce. We investigated the efficacy of EcN as an add-on therapy for UC. METHODS We conducted a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC. Overall, 133 eligible patients were randomly assigned to receive either EcN or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared. RESULTS In total, 58 and 60 patients in the EcN and placebo groups, respectively, completed the study. EcN was not superior to placebo in increasing the IBDQ scores (30 [51.7%] vs. 31 [51.7%], respectively; per-protocol, P= 1.0; intention-to-treat, P= 0.86). However, a significantly lower number of patients in the EcN group exhibited a decreased IBDQ score than those in the placebo group (1 [1.7%] vs. 8 [13.3%], respectively; per-protocol, P= 0.03; intention-to-treat, P= 0.02). Compared with the placebo group, a significantly high number of patients in the EcN group exhibited clinical response at 4 weeks (23 [39.7%] vs. 13 [21.7%], respectively; P= 0.04) and endoscopic remission at 8 weeks (26 [46.4%] vs. 16 [27.1%], respectively; P= 0.03). CONCLUSIONS EcN is safe and effective in preventing the exacerbation of IBDQ scores and achieving clinical responses and endoscopic remissions in patients with mild-to-moderate UC.