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

Abstract

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 ≤ 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.