Abstract Title:

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

Abstract Source:

Dig Endosc. 2015 Sep 29. Epub 2015 Sep 29. PMID: 26418574

Abstract Author(s):

Hiroyuki Tamaki, Hiroshi Nakase, Satoko Inoue, Chiharu Kawanami, Toshinao Itani, Masaya Ohana, Toshihiro Kusaka, Suguru Uose, Hiroshi Hisatsune, Masahide Tojo, Teruyo Noda, Souichi Arasawa, Masako Izuta, Atsushi Kubo, Chikara Ogawa, Toshihiro Matsunaka, Mitsushige Shibatouge

Article Affiliation:

Hiroyuki Tamaki


BACKGROUND AND AIM: We conducted a randomized, double-blinded, placebo-controlled trial to investigate the efficacy of Bifidobacterium longum 536 (BB536) supplementation for induction of remission in Japanese patients with active ulcerative colitis (UC).

METHODS: Fifty-six patients with mild to moderate UC were enrolled. Three patients had pancolitis, 36 had left-sided colitis, and 17 had proctitis. Patients were randomly treated with 2-3 × 10(11) freeze-dried viable BB536 (28 patients) or placebo (28 patients) for 8 weeks.

RESULTS: 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). We observed a significant decrease of UCDAI scores (3.8 ± 0.4 at baseline to 2.6 ± 0.4 at week 8) in the BB536 group (P < 0.01), whereas there was no significant decrease in the placebo group (P = 0.88). There was also a significant decrease in the Rachmilewitz endoscopic index (EI) and the Mayo subscore at week 8 in the BB536 group, whereas there was no significant decrease in the placebo group. A single patient in the BB536 group complained of a mild side-effect, but no other adverse effects were observed.

CONCLUSION: Supplementation with BB536 was well tolerated and reduced UCDAI scores, EI and Mayo subscores after 8 weeks in Japanese patients with mild to moderately active UC.

Study Type : Human Study

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