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

Crohn Disease Clinical Trial

Official title:

N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease：a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04761952
• Other study ID #: 2020ZSLYEC-292
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 13, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2021
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Polyunsaturated Acid Lipidosis
• Recurrence

Intervention

Drug:
• azathioprine
daily orally
• infliximab
intravenously, at 0, 2,6 weeks with every 8-week-interval later
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year postoperative anastomotic recurrence rate	anastomotic recurrence including endoscopic recurrence and imaging recurrence	1 year
Secondary	3 months postoperative anastomotic recurrence rate	anastomotic recurrence including endoscopic recurrence and imaging recurrence	3 months
Secondary	clinical recurrence rate	CDAI score larger than 150	3 months,1 year
Secondary	Inflammatory load	level of serum C- reactive protein	3 months,1 year
Secondary	Inflammatory load	level of serum fecal calprotectin	3 months,1 year
Secondary	Life quality SF-36	inflammatory bowel disease questionnaire and health survey summary table SF-36	3 months,1 year