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: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tamaki
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakase
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Satoko
authors.initials: S
authors.lastname: Inoue
authors.affiliation: Department of Gastroenterology, Kobe City Medical Center Hospital, Kobe, Japan.
authors.forename: Chiharu
authors.initials: C
authors.lastname: Kawanami
authors.affiliation: Department of Gastroenterology, Nishi Kobe Medical Center, Japan.
authors.forename: Toshinao
authors.initials: T
authors.lastname: Itani
authors.affiliation: Department of Gastroenterology, Tenri Hospital, Tenri, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Ohana
authors.affiliation: Digestive Disease Center, Kyoto-Katsura Hospital, Kyoto, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kusaka
authors.affiliation: Department of Gastroenterology, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Uose
authors.affiliation: Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hisatsune
authors.affiliation: Department of Gastroenterology, Otsu Red Cross Hospital, Otsu, Japan.
authors.forename: Masahide
authors.initials: M
authors.lastname: Tojo
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Teruyo
authors.initials: T
authors.lastname: Noda
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Souichi
authors.initials: S
authors.lastname: Arasawa
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Izuta
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kubo
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Chikara
authors.initials: C
authors.lastname: Ogawa
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Matsunaka
authors.affiliation: Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors.forename: Mitsushige
authors.initials: M
authors.lastname: Shibatouge
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001644:Bifidobacterium; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D012074:Remission Induction; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: induction of remission; microbiota; probiotic; randomized controlled trial; ulcerative colitis