drugset / Trial / NCT03537157

A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention

NCT03537157

Phase 2 Terminated 43 enrolled Alfasigma S.p.A. Cromsource · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Crohn's Disease (CD) is a chronic pathology characterized by exacerbations and remissions. Recurrent inflammation can cause bowel strictures, fistulae (often perianal) or abscesses. CD often requires intestinal resection. Surgery in CD is not curative, Therefore, endoscopic follow-up 6-12 months after surgery is recommended. Given the association between enteric bacteria and postoperative CD recurrence, antibacterial agents were shown to be effective in reducing the severity of endoscopic recurrence, but prolonged administration causes significant toxicity. The efficacy of "systemic antibiotics" and the experimental evidence of the central role of luminal flora as an essential factor in the development of post chirurgic CD recurrence provide the rationale for evaluating a locally acting antibiotic like Rifaximin.

Timeline

Start
2017-11-16
Primary completion
2020-07-15
Completion
2020-07-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 400 mg

Indications