Status:
UNKNOWN
N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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. Preventi...
Eligibility Criteria
Inclusion
- CD patients undergoing partial resection，anastomosis or enterostomy.
- age ≥18 to ≤80 years;
- have indications of AZA or IFX application (according to the consensus of ECCO 2016 years);
- Preoperative diagnosis CD, must provide the biopsy pathological record which accords with the CD diagnosis;
- If the subject is a woman of childbearing age, pregnancy tests must be conducted at baseline to exclude pregnancy, and the trial process must follow the contraceptive advice of this project
- subjects must be able and willing to provide written informed consent and comply with the requirements of this research program
Exclusion
- patients without indications use of AZA or IFX;
- isolated colon CD patients;
- patients who can't take long-term oral intervention of n-3PUFA;
- patients diagnosed with short bowel or short bowel syndrome;
- patients with severe, progressive or uncontrolled kidney, liver, blood or endocrine diseases;
- postoperative abdominal infection, anastomotic fistula and other complications;
- there's an infection, Such as Clostridium difficile toxin or other intestinal pathogens infection, active tuberculosis or intestinal tuberculosis, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C;
- patients with a history of gastrointestinal dysplasia; patients with
- TPMT gene mutations or low activity;
- patients who has already participated in other clinical trial.
Key Trial Info
Start Date :
February 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04761952
Start Date
February 13 2021
End Date
December 31 2023
Last Update
February 21 2021
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