P534 Efficacy of probiotic treatment with Bifidobacterium longum 536 for induction of remission in active ulcerative colitis: a randomized, double-blinded, placebo-controlled multicenter trial
H. Tamaki*1, M. Shibatoge1, H. Nakase2
1Takamatsu Red Cross Hospital, Gastroenterology, Takamatsu, Japan, 2Kyoto university, Gastroenterology and Hepatology, Kyoto, Japan
Probiotic treatment in patients with ulcerative colitis (UC) has been focused on improving the intestinal microbial balance and cytokine profile. We have previously reported that upregulation of T-bet and tight junction molecules by Bifidobacterium longum 536 (BB536) improves colonic inflammation in patients with UC. Therefore, to investigate the efficacy of BB536 supplementation for induction of remission in patients with active UC, we conducted a randomized, double-blinded, placebo-controlled multicenter trial.
A total of 56 consecutive patients with mild-to-moderate UC (27 male, 29 female; mean age 44 ± 14) were enrolled in the study. Eight patients of these (14%) were affected with pancolitis and 31 (56%) had left-sided colitis; 17 (30%) had proctitis. Patients were randomly treated with 2-3 × 1011 freeze-dried viable BB536 (28 patients) or placebo (28 patients) for 8 weeks.
Twenty-four patients in the BB536 group and 23 patients in the placebo group completed the study (86% and 82%, respectively). In 7 of the remaining 9 patients, other treatments were needed because of exacerbation. One patient from the BB536 group withdrew from the study because of a mild side effect, and 1 patient from the placebo group withdrew from the study on entry. In total, 63% of patients receiving BB536 showed clinical remission (UC disease activity index (UCDAI), ≤ 2) at week 8 compared to 52% of those receiving placebo (p = 0.395). There was a significant decrease in UCDAI scores from 3.5 ± 1.9 at baseline to 2.5 ± 1.7 at week 8 in the BB536 group (p = 0.034), whereas there was no significant decrease in these scores in the placebo group. Regarding endoscopic improvement, there were significant decrease in the EI score at week 8 in the BB536 group and placebo group (Wilcoxon t-test). None of the patients in the BB536 group experienced a worsening of EI score during the follow-up, whereas two patients in the placebo group showed a worsening. One patient (1.8%) in the BB536 group reported a mild side effect (dry cough), but no other serious adverse reactions were observed.
Supplementation with BB536 was well-tolerated and reduced UCDAI and EI scores after 8 weeks in Japanese patients with mild-to-moderately active UC.