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

• Status: Terminated
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfasigma S.p.A.
• Collaborator: Cromsource
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Crohn Disease with curative ileocolonic resection

• Randomization within 45 days from ileocolonic resection or end or loop ileostomy within last year and closure occurred within 45 days from randomization

• Fecal stream restoration at least 14 days prior to randomization

• Presence of at least one risk factor for recurrence

• Pregnancy protection on board during the study for childbearing female subjects

Exclusion Criteria:

• Presence of CD proximally or distally to the site of resection

• Patients with strictureplasties at index surgery or ileorectal anastomosis

• patients with active perianal CD

• Patient treated with other treatments usually utilised for CD

• Patients with active diseases with gastrointestinal involvement

• intestinal obstruction or pseudo-obstruction

• Patients presenting diarrhoea plus fever or bloody stools

• Positivity to clostridium difficile toxin

• Severe hepatic or renal impairment

• Presence of severe cardiac insufficiency

• Hypersensitivity to rifamycin antimicrobial agents

• other conditions that would interfere or prevent the study completion

• Pregnancy