title: Clinical effectiveness of probiotics therapy (BIO-THREE) in patients with ulcerative colitis refractory to conventional therapy.
abstract: OBJECTIVE
  Intestinal microflora has been implicated in the etiology of ulcerative colitis (UC). Over the past few years, the use of probiotics in UC has gained attention. The aim of this study was to evaluate the efficacy of probiotics therapy for mild to moderate distal UC refractory to conventional therapies.
  
  
  METHODS
  Twenty patients with mild to moderate distal UC took 9 BIO-THREE tablets per day for 4 weeks. Clinical symptoms and endoscopic findings were evaluated as ulcerative colitis disease activity index (UCDAI) scores before and after administration of BIO-THREE. Fecal samples were collected from all patients before and after probiotics administration, and fecal microflora was analyzed by the terminal restriction fragment length polymorphism (T-RFLP) method.
  
  
  RESULTS
  Remission (UCDAI score < or =2) was observed in 45% (9/20) of the patients; response (decrease in UCDAI > or = 3, but final score > or = 3) in 10% (2/20); no response in 40% (8/20); and worsening (UCDAI > 3) in 5% (1/20). T-RFLP analysis indicated that the principal alteration in microflora was an increase in bifidobacteria.
  
  
  CONCLUSIONS
  This study showed that administration of BIO-THREE improved the clinical symptoms and endoscopic findings in patients with UC, indicating that administration of BIO-THREE is safe and efficacious for the treatment of UC.
authors.affiliation: Department of Internal Medicine, Sakura Medical Center, Toho University, Chiba, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Tsuda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Yoshimatsu
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Aoki
authors.forename: Kentaro
authors.initials: K
authors.lastname: Nakamura
authors.forename: Masaki
authors.initials: M
authors.lastname: Irie
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Fukuda
authors.forename: Nobuo
authors.initials: N
authors.lastname: Hosoe
authors.forename: Nobuo
authors.initials: N
authors.lastname: Takada
authors.forename: Koji
authors.initials: K
authors.lastname: Shirai
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
mesh_terms: D000328:Adult; D000368:Aged; D001419:Bacteria / Q000145:classification / Q000235:genetics; D003093:Colitis, Ulcerative / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D016172:DNA Fingerprinting; D004724:Endoscopy; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012150:Polymorphism, Restriction Fragment Length; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index