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

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

Outcome

Outcome not reported

Stopped (Enrollment): “The decision to prematurely close the trial recruitment period was taken due to the difficulties in the recruitment of patients. This decision has not been triggered by any unexpected safety signals identified during the study conduction.”

Drugs

Indications