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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Polyunsaturated Acid Lipidosis
• Intervention / Treatment: Drug: azathioprine; Drug: infliximab; Drug: N-3 Polyunsaturated Fatty Acids

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: azathioprine; daily orally; Other Names: AZA; Drug: infliximab; intravenously, at 0, 2,6 weeks with every 8-week-interval later; Other Names: IFX; 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.; Other Names: n-3PUFA
Placebo Comparator: 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.	Drug: azathioprine; daily orally; Other Names: AZA; Drug: infliximab; intravenously, at 0, 2,6 weeks with every 8-week-interval later; Other Names: IFX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year postoperative anastomotic recurrence rate	anastomotic recurrence including endoscopic recurrence and imaging recurrence	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 13, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Disease Attributes; Gastrointestinal Diseases; Genetic Diseases, Inborn; Gastroenteritis; Intestinal Diseases; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Inflammatory Bowel Diseases; Recurrence; Crohn Disease; Lipidoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Infliximab; Azathioprine
• Other Study ID Numbers: 2020ZSLYEC-292

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No