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. 2019 Aug 6;2019(8):CD010233. doi: 10.1002/14651858.CD010233.pub3

NCT03185611.

Trial name or title Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
Methods RCT, parallel design, multi‐centre study, single blinded (Outcomes Assessor); Location: China
Participants 120 participants, aged 18 to 65 years
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 co‐morbidities;

  2. With a stoma;

  3. With malignancy;

  4. Pregnancy;

  5. Intolerant of thiopurine drugs;

  6. With contraindication of using rifaximin or thiopurine drug

Interventions Two arms; Arm 1: 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 to 2.5 mg/kg/day) for the next 3 months and Arm 2: Prescribed Azathioprine (2.0 to 2.5 mg/kg/day) for 6 months after surgery
Outcomes Primary: Incidence of endoscopic recurrence 6 months after surgery
Secondary: Adverse effect
Starting date June 14, 2017
Contact information Xiang Gao, MD, PhD; gaoxiangmed@163.com
Notes