title: Open label trial of clarithromycin therapy in Japanese patients with Crohn's disease.
abstract: OBJECTIVE
  The pathogenesis of Crohn's disease is unclear, but many studies suggest that luminal bacteria play an important role in chronic intestinal inflammation in patients with this condition. Clarithromycin is a macrolide antibiotic with immunomodulatory activity. The aim of this study was to evaluate the effect of clarithromycin therapy in Japanese patients with Crohn's disease.
  
  
  METHODS
  Fourteen patients with active Crohn's disease (12 with ileocolonic, one with colonic, one with small bowel type) were treated with oral clarithromycin 200 mg twice daily for 4 weeks. Patients who showed a clinical response within 4 weeks continued the therapy for up to 24 weeks. Four patients also received azathioprine. Clinical activity was assessed with the Crohn's Disease Activity Index (CDAI) at entry and at 4, 12, and 24 weeks after starting clarithromycin.
  
  
  RESULTS
  The mean CDAI score at entry was 343.5. Within 4 weeks, eight (57.1%) of the 14 patients showed clinical improvement, and five (35.7%) of the eight patients achieved remission. All of those eight patients continued clarithromycin therapy after 4 weeks, and six (42.9%) were in clinical remission at 12 weeks. Of the 14 total patients, four (28.6%) continued clarithromycin for more than 24 weeks, and have remained in remission. Patients who received azathioprine concomitantly had a better response to clarithromycin therapy. No severe side-effects were observed during the study period.
  
  
  CONCLUSIONS
  This open label study showed encouraging results of clarithromycin therapy in Japanese patients with active Crohn's disease.
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University Hospital, Sakyo-ku, Kyoto, Japan.
authors.forename: Satoko
authors.initials: S
authors.lastname: Inoue
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakase
authors.forename: Minoru
authors.initials: M
authors.lastname: Matsuura
authors.forename: Satoru
authors.initials: S
authors.lastname: Ueno
authors.forename: Norimitsu
authors.initials: N
authors.lastname: Uza
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kitamura
authors.forename: Sakae
authors.initials: S
authors.lastname: Mikami
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tamaki
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Kasahara
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Chiba
mesh_terms: D000328:Adult; D017291:Clarithromycin / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011500:Protein Synthesis Inhibitors / Q000627:therapeutic use*
chemical_list: D011500:Protein Synthesis Inhibitors; D017291:Clarithromycin