Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2017
CompletedFirst Submitted
Initial submission to the registry
June 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedJune 14, 2017
June 1, 2017
9 months
June 11, 2017
June 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse effect
6 months after surgery
Study Arms (2)
Rifaximin and Thiopurine
EXPERIMENTALPrescribed 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
ACTIVE COMPARATORPrescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe comorbidities;
- With a stoma;
- With malignancy;
- Pregnancy;
- Intolerant of thiopurine drugs;
- With contraindication of using rifaximin or thiopurine drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen Universitylead
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
- Xijing Hospitalcollaborator
- Shanghai 10th People's Hospitalcollaborator
- RenJi Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
Study Sites (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2017
First Posted
June 14, 2017
Study Start
May 18, 2017
Primary Completion
January 31, 2018
Study Completion
July 31, 2018
Last Updated
June 14, 2017
Record last verified: 2017-06