Crohn's disease (CD) is a chronic recurrent intestinal inflammation involving the whole digestive tract, with high disability rate, high surgical rate and high recurrent rate postoperatively. Preventing postoperative recurrence in CD patients is an important clinical problem needed urgent intervention. Azathioprine (AZA) and infliximab (IFX) effectively prevent postoperative recurrence in CD patients, but the postoperative recurrence rate is still as high as 41%. Oral supplement of n-3 polyunsaturated fatty acids (n-3 PUFA) owns the advantages of high compliance and low economic cost. We aim to evaluate the effect of routine treatment (AZA/IFX) combined with long-term dietary n-3PUFA on the prevention and treatment of postoperative recurrence of CD, which help optimize the treatment strategy for the prevention of postoperative recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
236
daily orally
intravenously, at 0, 2,6 weeks with every 8-week-interval later
Ethyl polyenoate capsule is given as drug intervention. The main components are ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoate (DHA-E), both of which will transform into ethyl eicosapentaenoate (EPA) and ethyl docosahexaenoate (DHA). Drug dose is 0.25 g EPA-E\&DHA-E; per capsule one at a time, Three times a day.
1 year postoperative anastomotic recurrence rate
anastomotic recurrence including endoscopic recurrence and imaging recurrence
Time frame: 1 year
3 months postoperative anastomotic recurrence rate
anastomotic recurrence including endoscopic recurrence and imaging recurrence
Time frame: 3 months
clinical recurrence rate
CDAI score larger than 150
Time frame: 3 months,1 year
Inflammatory load
level of serum C- reactive protein
Time frame: 3 months,1 year
Inflammatory load
level of serum fecal calprotectin
Time frame: 3 months,1 year
Life quality SF-36
inflammatory bowel disease questionnaire and health survey summary table SF-36
Time frame: 3 months,1 year
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