Overview

Effectiveness of Rifaximin Combined With Thiopurine 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 combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.

Phase:

Phase 3

Accepts Healthy Volunteers?

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:

Azathioprine
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 must have one or more 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. Intolerant of thiopurine drugs;

6. With contraindication of using rifaximin or thiopurine drugs.