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

Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Rifaximin; Drug: Azathioprine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiang Gao, MD, PhD; Phone Number: 020-38663423; Email: gaoxiangmed@163.com

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Xiang Gao, MD, PhD; Phone Number: 020-38663423; Email: gaoxiangmed@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifaximin and Thiopurine; 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.	Drug: Rifaximin; Antibiotics; Drug: Azathioprine; immunomodulator
Active Comparator: Thiopurine; Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery.	Drug: Azathioprine; immunomodulator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect	Adverse effect of Rifaximin	6 months after surgery

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Xijing Hospital; Peking Union Medical College Hospital; First Affiliated Hospital, Sun Yat-Sen University; RenJi Hospital; Shanghai 10th People's Hospital; Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Anticipated): January 31, 2018
• Study Completion (Anticipated): July 31, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Azathioprine
• Other Study ID Numbers: 2017-ZSLY-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No