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

Phase 3

• Conditions: Crohn Disease
• Interventions: Drug: Rifaximin; Drug: Azathioprine

• Registration Number: NCT03185611
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-18
• Status Verified: 2017-06
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-01-31
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin and Thiopurine	Rifaximin	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.
Rifaximin and Thiopurine	Azathioprine	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.
Thiopurine	Azathioprine	Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse effect	6 months after surgery	Adverse effect of Rifaximin

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guanzhou, Guangdong, China