drugset / Trial / NCT03185611
Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
Phase 3
Unknown
120 enrolled
Sixth Affiliated Hospital, Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University · collabPeking Union Medical College Hospital · collabRenJi Hospital · collabShanghai 10th People's Hospital · collabSir Run Run Shaw Hospital · collabXijing Hospital · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2017-05-18
- Primary completion
- 2018-01-31
- Completion
- 2018-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 2 mg/kg | — |
| Subject | Azathioprine | Small molecule | 2.5 mg/kg | — |
| Subject | Rifaximin | Other / unclassified | 600 mg | — |