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Randomized Controlled Trial
. 2010 Apr 15:10:13.
doi: 10.1186/1472-6882-10-13.

Clinical trial: probiotic treatment of acute distal ulcerative colitis with rectally administered Escherichia coli Nissle 1917 (EcN)

Harald Matthes  1 , Thomas Krummenerl, Manfred Giensch, Corinna Wolff, Jürgen Schulze
Affiliations
Randomized Controlled Trial

Clinical trial: probiotic treatment of acute distal ulcerative colitis with rectally administered Escherichia coli Nissle 1917 (EcN)

Harald Matthes et al. BMC Complement Altern Med. .

Abstract

Background: Probiotics are effective in inflammatory bowel diseases. Clinical effectiveness and dose dependency of E. coli Nissle (EcN) enemas were investigated in ulcerative colitis (UC).

Methods: In a double-blind study, 90 patients with moderate distal activity in UC were randomly assigned to treatment with either 40, 20, or 10 ml enemas (N = 24, 23, 23) containing 10E8 EcN/ml or placebo (N = 20). The study medication was taken once daily for at least 2 weeks. After 2, 4 and/or 8 weeks the clinical DAI was assessed together with tolerance to treatment. Patients who reached clinical DAI <or= 2 within that time were regarded as responders.

Results: According to ITT analysis the number of responders was not significantly higher in the EcN group than in the placebo group (p = 0.4430, 2-sided). However, the Jonckheere-Terpstra rank correlation for dose-dependent efficacy indicated a significant correlation of per-protocol responder rates (p = 0.0446, 2-sided). Time to remission was shortest with EcN 40 ml, followed by EcN 20 ml. The number of adverse events did not differ notably.

Conclusion: In contrast to ITT analysis, efficacy of rectal EcN application was significant in PP and points to EcN as a well tolerated treatment alternative in moderate distal UC.

Trial registration: German Clinical Trials Register DRK00000234.

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Figures

Figure 1
Figure 1
Patient flow chart.
Figure 2
Figure 2
Time to remission, per-protocol analysis (N = 57) and intention-to-treat analysis (N = 88).
Figure 3
Figure 3
Changes in histological findings in rectum, intention-to-treat analysis (N = 88).
Figure 4
Figure 4
Course of clinical DAI between admission and end of treatment (LOCF), per- protocol analysis (N = 57).
See this image and copyright information in PMC

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