See Appendix 1 for the list of Centres that participated in Grace 01 study.
Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin
Article first published online: 30 MAR 2006
Alimentary Pharmacology & Therapeutics
Volume 23, Issue 8, pages 1117–1125, April 2006
How to Cite
PRANTERA, C., LOCHS, H., CAMPIERI, M., SCRIBANO, M. L., STURNIOLO, G. C., CASTIGLIONE, F. and COTTONE, M. (2006), Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin. Alimentary Pharmacology & Therapeutics, 23: 1117–1125. doi: 10.1111/j.1365-2036.2006.02879.x
- Issue published online: 30 MAR 2006
- Article first published online: 30 MAR 2006
- Publication data Submitted 14 December 2005 First decision 31 December 2005 Resubmitted 6 February 2006 Accepted 6 February 2006
Background Clinicians often employ antibiotics in Crohn's disease. Rifaximin is active against bacteria frequently found in the intestinal mucosa of Crohn's disease patients.
Aim To evaluate the difference in efficacy between once and twice/daily oral administration of rifaximin and placebo in the treatment of active Crohn's disease.
Methods We enrolled 83 patients with mild-to-moderate Crohn's disease and randomized to three treatments for 12 weeks: Group A (rifaximin 800 mg o.d. + placebo), Group B (rifaximin 800 mg b.d.) and Group C (placebo b.d.).
Results Clinical remission was achieved by 52% of Group B, 32% (A) and 33% (C). Clinical response was seen in 67% (B), 48% (A) and 41% (C), without reaching a statistically significant difference. Treatment failures were: 4% (B), 12% (A) and 33% (C), (P = 0.010). Remission and response rates of rifaximin 800 mg b.d. were significantly higher than those of placebo and rifaximin 800 mg o.d. in patients with elevated C reactive protein values (P < 0.05).
Conclusions Rifaximin 800 mg b.d. was superior to placebo in inducing clinical remission of active Crohn's disease. Although this difference was not statistically significant, the number of the failures in the placebo group was significantly higher than those who received rifaximin 800 mg b.d.