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

BMC Complementary and Alternative Medicine

Research Article

Corinna Wolff¹  Jürgen Schulze¹  Harald Matthes²  Manfred Giensch³  Thomas Krummenerl⁴ 

[1] Ardeypharm GmbH, Loerfeldstr. 20, 58313, Herdecke, Germany;Department of Gastroenterology, Community Hospital Havelhoehe, Kladower Damm 221, 14089, Berlin, Germany;Private Practice, Am Wall 1, 21073, Hamburg, Germany;Private Practice, An der Germania Brauerei 6, 48159, Muenster, Germany;

关键词: Ulcerative Colitis;    Disease Activity Index;    Last Observation Carry Forward;    Aminosalicylates;    Escherichia Coli Nissle;   

DOI  :  10.1186/1472-6882-10-13

 received in 2009-09-03, accepted in 2010-04-15,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundProbiotics are effective in inflammatory bowel diseases. Clinical effectiveness and dose dependency of E. coli Nissle (EcN) enemas were investigated in ulcerative colitis (UC).MethodsIn 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.ResultsAccording 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.ConclusionIn 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 registrationGerman Clinical Trials Register DRK00000234.

【 授权许可】

CC BY   
© Matthes et al; licensee BioMed Central Ltd. 2010