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

Overview

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.

Full Title of Study: “Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn’s Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2018

Interventions

  • Drug: Rifaximin
    • Antibiotics

Arms, Groups and Cohorts

  • Experimental: Rifaximin
    • Prescribed Rifaximin (600mg, twice daily) for 3 months after surgery
  • No Intervention: Blank control
    • No intervention after surgery

Clinical Trial Outcome Measures

Primary Measures

  • difference of incidence of endoscopic recurrence
    • Time Frame: 6 months after surgery
    • Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al.

Secondary Measures

  • Adverse effect
    • Time Frame: 6 months after surgery
    • Adverse effect of Rifaximin

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sixth Affiliated Hospital, Sun Yat-sen University
  • Collaborator
    • First Affiliated Hospital, Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Xiang Gao, MD, PhD, 020-38663423, gaoxiangmed@163.com

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