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


CONCLUSIONS
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.


BACKGROUND
German Clinical Trials Register DRK00000234.
Matthes
Harald
H
Department of Gastroenterology, Community Hospital Havelhoehe, Kladower Damm 221, 14089 Berlin, Germany. hmatthes@havelhoehe.de
Krummenerl
Thomas
T
Giensch
Manfred
M
Wolff
Corinna
C
Schulze
Jürgen
J
D000208:Acute Disease; D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D001688:Biological Products / Q000008:administration & dosage / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004733:Enema; D004926:Escherichia coli; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D001688:Biological Products
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