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

Not Applicable

• Conditions: Inflammatory Bowel Diseases; Polyunsaturated Acid Lipidosis; Crohn Disease
• Interventions: Drug: azathioprine; Drug: infliximab; Drug: N-3 Polyunsaturated Fatty Acids

• Registration Number: NCT04761952
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-13
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n-3PUFA treatment group	N-3 Polyunsaturated Fatty Acids	On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.
Conventional treatment group	infliximab	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.
n-3PUFA treatment group	azathioprine	On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.
n-3PUFA treatment group	infliximab	On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.
Conventional treatment group	azathioprine	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.

Primary Outcome Measures

Name	Time	Method
1 year postoperative anastomotic recurrence rate	1 year	anastomotic recurrence including endoscopic recurrence and imaging recurrence

Secondary Outcome Measures

Name	Time	Method
Inflammatory load	3 months，1 year	level of serum fecal calprotectin
clinical recurrence rate	3 months，1 year	CDAI score larger than 150
3 months postoperative anastomotic recurrence rate	3 months	anastomotic recurrence including endoscopic recurrence and imaging recurrence
Life quality SF-36	3 months，1 year	inflammatory bowel disease questionnaire and health survey summary table SF-36