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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Xijing Hospital | OTHER |
| Shanghai 10th People's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin and Thiopurine | Experimental | 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. |
|
| Thiopurine | Active Comparator | Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Antibiotics |
| |
| Azathioprine |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | Adverse effect of Rifaximin | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Gao, MD, PhD | Contact | 020-38663423 | gaoxiangmed@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guanzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| RenJi Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
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| Drug |
immunomodulator |
|
| D007410 | Intestinal Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |