N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease

NCT ID: NCT04761952

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-13
• Study Completion Date: 2023-12-31

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. 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Polyunsaturated Acid Lipidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

n-3PUFA treatment group

On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.

Group Type: EXPERIMENTAL

azathioprine

Intervention Type: DRUG

daily orally

infliximab

Intervention Type: DRUG

intravenously, at 0, 2,6 weeks with every 8-week-interval later

N-3 Polyunsaturated Fatty Acids

Intervention Type: DRUG

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.

Conventional treatment group

Treatment of azathioprine (daily orally) or infliximab (intravenously, at 0, 2,6 weeks with every 8-week-interval later) was given since 2-week-postoperative till 1-year-postoperative.

Group Type: PLACEBO_COMPARATOR

azathioprine

Intervention Type: DRUG

daily orally

infliximab

Intervention Type: DRUG

intravenously, at 0, 2,6 weeks with every 8-week-interval later

Interventions

azathioprine

daily orally

Intervention Type: DRUG

infliximab

intravenously, at 0, 2,6 weeks with every 8-week-interval later

Intervention Type: DRUG

N-3 Polyunsaturated Fatty Acids

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.

Intervention Type: DRUG

Other Intervention Names

AZA; IFX; n-3PUFA

Eligibility Criteria

Inclusion Criteria

1. CD patients undergoing partial resection，anastomosis or enterostomy.

2. age ≥18 to ≤80 years;

3. have indications of AZA or IFX application (according to the consensus of ECCO 2016 years);

4. Preoperative diagnosis CD, must provide the biopsy pathological record which accords with the CD diagnosis;

5. 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

6. subjects must be able and willing to provide written informed consent and comply with the requirements of this research program

Exclusion Criteria

1. patients without indications use of AZA or IFX;

2. isolated colon CD patients;

3. patients who can't take long-term oral intervention of n-3PUFA;

4. patients diagnosed with short bowel or short bowel syndrome;

5. patients with severe, progressive or uncontrolled kidney, liver, blood or endocrine diseases;

6. postoperative abdominal infection, anastomotic fistula and other complications;

7. 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;

8. patients with a history of gastrointestinal dysplasia; patients with

9. TPMT gene mutations or low activity;

10. patients who has already participated in other clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2020ZSLYEC-292

Identifier Type: -

Identifier Source: org_study_id