Efficacy of probiotic treatment with Bifidobacterium longum 536 for induction of remission in active ulcerative colitis: a randomized, double-blinded, placebo-controlled multicenter trial

Objective Bifidobacterium longum (BB536) is one of the probiotics reported that upregulation of T-bet and tight junction molecules by BB536 improves colonic inflammation in patients with UC. 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.Methods A total of 56 consecutive patients with mild-to-moderate UC (27 male, 29 female; mean age 44±14) were enrolled in the study. Patients were randomly treated with 15*10¹⁰ freeze-dried viable BB536 (28 patients) or placebo (28 patients) for 8 weeks. Results Twenty-four patients in the BB536 group and 23 patients in the placebo group completed the study. In total, 63% of patients receiving BB536 showed clinical remission (UC disease activity index [UCDAI], <3) at week 8 compared to 52% of those receiving placebo (p=0.395). There was a significant decrease in UCDAI scores at week 8 in the BB536 group (p=0.034), whereas there was no significant decrease in these scores in the placebo group. The Rachmilewitz endoscopic index (EI) score also decreased significantly in the BB536 group (p=0.014) whereas there was no significant decrease in the placebo group. Conclusions Supplementation with BB536 was efficacious in ameliorating the disease activity in patients with mild-to-moderate UC.