Antibiotic treatment of Crohn's disease

results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin

PRANTERA, C.
LOCHS, H.
CAMPIERI, M.
SCRIBANO, M. L.
STURNIOLO, G. C.
CASTIGLIONE, F.
COTTONE, M.

^*Operative Unit of Gastroenterology, St Camillo-Forlanini Hospital, Rome, Italy
†Department of Gastroenterology, Hepatology and Endocrinology, Charité University Hospital, Berlin, Germany
‡IBD Unit, Department of Internal Medicine and Gastroenterology, St Orsola-Malpighi University Hospital, Bologna, Italy
§Operative Unit of Gastroenterology, Padova University Hospital, Padova, Italy
¶Operative Unit of Gastroenterology, ‘Federico II’ University Hospital, Naples, Italy
^**Medical Clinic ‘R’, Institute of General Medicine and Pneumology, ‘V. Cervello’ Hospital, Palermo, Italy

Correspondence to: Dr Cosimo Prantera, Unità Operativa di Gastroenterologia, Azienda Ospedaliera S Camillo-Forlanini, Circonvallazione Gianicolense, 87 – 00152 Rome, Italy. E-mail: [email protected]

¹See Appendix 1 for the list of Centres that participated in Grace 01 study.

Publication data Submitted 14 December 2005 First decision 31 December 2005 Resubmitted 6 February 2006 Accepted 6 February 2006

Alimentary Pharmacology & Therapeutics 23(8):p 1117-1125, April 2006.

Summary

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.