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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Azathioprine
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rifaximin and Thiopurine

Thiopurine

Arm 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.

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

Outcomes

Primary Outcome Measures

difference of incidence of endoscopic recurrence
Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al.

Secondary Outcome Measures

Adverse effect
Adverse effect of Rifaximin

Full Information

First Posted
June 11, 2017
Last Updated
June 12, 2017
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, Xijing Hospital, Shanghai 10th People's Hospital, RenJi Hospital, Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03185611
Brief Title
Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, Xijing Hospital, Shanghai 10th People's Hospital, RenJi Hospital, Sir Run Run Shaw Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin and Thiopurine
Arm Type
Experimental
Arm 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.
Arm Title
Thiopurine
Arm Type
Active Comparator
Arm Description
Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Antibiotics
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Intervention Description
immunomodulator
Primary Outcome Measure Information:
Title
difference of incidence of endoscopic recurrence
Description
Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Adverse effect
Description
Adverse effect of Rifaximin
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis; 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: Severe comorbidities; With a stoma; With malignancy; Pregnancy; Intolerant of thiopurine drugs; With contraindication of using rifaximin or thiopurine drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Gao, MD, PhD
Phone
020-38663423
Email
gaoxiangmed@163.com
Facility Information:
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Gao, MD, PhD
Phone
020-38663423
Email
gaoxiangmed@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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