Hiroyuki Tamaki1, Hiroshi Nakase2, Satoko Inoue2, Chiharu Kawanami3, Toshinao Itani4, Masaya Ohana5, Toshihiro Kusaka6, Suguru Uose7, Hiroshi Hisatsune8, Masahide Tojo9, Teruyo Noda1, Souichi Arasawa1, Masako Izuta1, Atsushi Kubo1, Chikara Ogawa1, Toshihiro Matsunaka1, Mitsushige Shibatouge1. 1. Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan. 2. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University Hospital, Kyoto, Japan. 3. Department of Gastroenterology, Kobe City Medical Center Hospital, Kobe, Japan. 4. Department of Gastroenterology, Nishi Kobe Medical Center, Japan. 5. Department of Gastroenterology, Tenri Hospital, Tenri, Japan. 6. Digestive Disease Center, Kyoto-Katsura Hospital, Kyoto, Japan. 7. Department of Gastroenterology, Kansai Electric Power Hospital, Osaka, Japan. 8. Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan. 9. Department of Gastroenterology, Otsu Red Cross Hospital, Otsu, Japan.
Abstract
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.
RCT Entities:
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.
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