title: A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome.
abstract: OBJECTIVE
  To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most.
  
  
  BACKGROUND
  Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising.
  
  
  METHODS
  Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (n = 60) given for 12 weeks. Objectives were to describe efficacy and safety of EcN in different groups of irritable bowel syndrome. Outcome was assessed by 'Integrative Medicine Patient Satisfaction Scale'.
  
  
  RESULTS
  Altogether, the responder rate was higher in the EcN than in the placebo group. However, only after 10 and 11 weeks, the differences were significant (Δ 20.0% points [95% CI 2.6; 37.4], p = 0.01 and Δ 18.3% points [95% CI 1.0; 35.7], p = 0.02, respectively). The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset (Δ 45.7% points, p = 0.029). No significant differences were observed in any other subgroup. Both treatment groups showed similar adverse events and tolerance.
  
  
  CONCLUSIONS
  Probiotic EcN shows effects in irritable bowel syndrome, especially in patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics.
authors: Evangelisches Krankenhaus Kalk, University of Cologne, Buchforststrasse 2, 51103, Cologne, Germany. kruis@evkk.de
authors: Wolfgang
authors: W
authors: Kruis
authors: Sigrun
authors: S
authors: Chrubasik
authors: Stephan
authors: S
authors: Boehm
authors: Christiane
authors: C
authors: Stange
authors: Juergen
authors: J
authors: Schulze
mesh_terms: D016009:Chi-Square Distribution; D003710:Demography; D004311:Double-Blind Method; D004926:Escherichia coli / Q000378:metabolism*; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D010919:Placebos