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Clinical Trial
. 2004 Nov;53(11):1617-23.
doi: 10.1136/gut.2003.037747.

Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine

W Kruis  1 , P Fric, J Pokrotnieks, M Lukás, B Fixa, M Kascák, M A Kamm, J Weismueller, C Beglinger, M Stolte, C Wolff, J Schulze
Affiliations
Clinical Trial

Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine

W Kruis et al. Gut. 2004 Nov.

Abstract

Background and aims: 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.

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Figures

Figure 1
Figure 1
Number of patients in the study at the time of clinical visits and at the final examination.
Figure 2
Figure 2
Proportion of patients experiencing a relapse of ulcerative colitis in the Escherichia coli Nissle 1917 (EcN) and mesalazine groups.
Figure 3
Figure 3
Probability of remaining in remission in the Escherichia coli Nissle 1917 (EcN) and mesalazine groups.
Figure 4
Figure 4
Endoscopic index and histology at the start and end of the study in the Escherichia coli Nissle 1917 (EcN) and mesalazine groups.
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References

    1. British Society of Gastroenterology. Clinical practice guidelines: inflammatory bowel disease. 1996. www.bsg.org.uk/clinical-prac/guidelines.htm.
    1. Stange EF, Riemann J, von Herbay A, et al. Diagnosis and therapy of ulcerative colitis—results of an evidence-based consensus conference of the German Society of Digestive and Metabolic Diseases. Z Gastroenterol 2001;39:19–20. - PubMed
    1. Travis SP, Jewell DP. Salicylates for ulcerative colitis—their mode of action. Pharmacol Ther 1994;63:135–61. - PubMed
    1. Shanahan F . Probiotics and inflammatory bowel disease: is there a scientific rationale? Inflamm Bowel Dis 2000;6:107–15. - PubMed
    1. D’Haens GR, Geboes K, Peeters M, et al. Early lesions of recurrent Crohn’s disease caused by infusion of intestinal contents in excluded ileum. Gastroenterology 1998;114:262–7. - PubMed

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