Crohn Disease
Conditions
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.
Interventions
DRUGRifaximin
Antibiotics
Sponsors
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
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 without 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. With contraindication of using rifaximin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference of incidence of endoscopic recurrence | 6 months after surgery | Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | 6 months after surgery | Adverse effect of Rifaximin |
Countries
China
Contacts
Primary ContactXiang Gao, MD, PhD
Outcome results
None listed