title: Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis: a double-blind randomized placebo controlled clinical trial.
abstract: OBJECTIVE
  Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC.
  
  
  METHODS
  Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1week followed by EcN or placebo for 7weeks. All 4 treatments were given as add-on treatments.
  
  
  RESULTS
  One hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p<0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p<0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p<0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively.
  
  
  CONCLUSIONS
  Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.
authors: Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark; Department of Clinical Microbiology, Hvidovre University Hospital, Copenhagen, Denmark. Electronic address: munk@dadlnet.dk.
authors: Andreas Munk
authors: AM
authors: Petersen
authors: Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, Denmark.
authors: Hengameh
authors: H
authors: Mirsepasi
authors: Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark.
authors: Sofie Ingdam
authors: SI
authors: Halkjær
authors: Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark.
authors: Esben Munk
authors: EM
authors: Mortensen
authors: Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark.
authors: Inge
authors: I
authors: Nordgaard-Lassen
authors: Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, Denmark.
authors: Karen Angeliki
authors: KA
authors: Krogfelt
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D004926:Escherichia coli; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects; D008297:Male; D010352:Patient Dropouts; D010919:Placebos / Q000627:therapeutic use; D019936:Probiotics / Q000627:therapeutic use*; D012074:Remission Induction; D012720:Severity of Illness Index; D014945:Wound Healing
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D002939:Ciprofloxacin
keywords: Ciprofloxacin; E. coli Nissle; Escherichia coli; Ulcerative colitis