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PROBIOTICS |
2,
J Pokrotnieks3,
M Luká
4,
B Fixa5,
M Kaák6,
M A Kamm7,
J Weismueller8,
C Beglinger9,
M Stolte10,
C Wolff11,
J Schulze11
1 Evangelisches Krankenhaus Kalk, University of Cologne, Germany
2 Ust
edná vojenská nemocnice, II interní odd
lení, Praha, Czech Republic
3 Paula Stradina Clinical University Hospital, Riga, Latvia
4 IV Interni Klinika, Charles University, Praha, Czech Republic
5 2nd Department of Medicine, Charles University Prague, Medical Faculty, Hradec Kralove, Czech Republic
6 Interné oddelenie NsP, Trenín, Slovak Republic
7 St Mark’s Hospital, London, UK
8 Private Practice, Koblenz, Germany
9 Division of Gastroenterology, University Hospital, Basel, Switzerland
10 Institut für Pathologie, Klinikum Bayreuth, Germany
11 Ardeypharm, Herdecke, Germany
Correspondence to:
Correspondence to:
Dr W Kruis
Evangelisches Krankenhaus Kalk, Buchforststr 2, 51103 Cologne, Germany; ansorg{at}evkk.de
ABSTRACT
Background and aim: Evidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalazine in patients with ulcerative colitis.
Patients and methods: In total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily (n = 162) or mesalazine 500 mg three times daily (n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rachmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses.
Results: The per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group (significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different.
Conclusions: The probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.
Abbreviations: UC, ulcerative colitis; IBD, inflammatory bowel disease; EcN, Escherichia coli Nissle 1917; GCP, good clinical practice; CAI, clinical activity index; EI, endoscopic index; ITT, intention to treat population; PP, per protocol population; 5-ASA, 5-aminosalicylic acid
Keywords: ulcerative colitis; maintenance therapy; probiotics; Escherichia coli Nissle
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