Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease

• Status: Unknown status
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Peking Union Medical College Hospital; RenJi Hospital; Shanghai 10th People's Hospital; Sir Run Run Shaw Hospital; Xijing Hospital
• Treatments: Mesalamine; Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;

2. Enrolled patients without risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;

2. With a stoma;

3. With malignancy;

4. Pregnancy;

5. With contraindication of using rifaximin.