Back to resultsEffectiveness of Rifaximin 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
Sponsored by
About this trial
This is an interventional prevention trial for Crohn Disease
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 without 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;
- With contraindication of using rifaximin.
Sites / Locations
- The Sixth Affiliated Hospital, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rifaximin
Blank control
Arm Description
Prescribed Rifaximin (600mg, twice daily) for 3 months after surgery
No intervention 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
NCT ID
NCT03185624
First Posted
June 11, 2017
Last Updated
July 18, 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
1. Study Identification
Unique Protocol Identification Number
NCT03185624
Brief Title
Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease
Official Title
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
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2017 (Anticipated)
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 on preventing postoperative endoscopic recurrence in Crohn's disease. 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
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Prescribed Rifaximin (600mg, twice daily) for 3 months after surgery
Arm Title
Blank control
Arm Type
No Intervention
Arm Description
No intervention after surgery
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Antibiotics
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 without 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;
With contraindication of using rifaximin.
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
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
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 on Preventing Postoperative Recurrence in Crohn's Disease
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