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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Azathioprine; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT03185611

2017-ZSLY-06

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Rifaximin and Thiopurine

Experimental group

Description:

Prescribed Rifaximin (600mg, twice daily) combined with Azathioprine (2.0-2.5mg/kg/day) for 3 months after surgery, and then Azathioprine monotherapy (2.0-2.5mg/kg/day) for the next 3months.

Treatment:

Drug: Azathioprine

Drug: Rifaximin

Thiopurine

Active Comparator group

Description:

Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery.

Treatment:

Drug: Azathioprine