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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04761952

Collaborator

(none)

236

Enrollment

Arms

34.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Crohn Disease Polyunsaturated Acid Lipidosis	Drug: azathioprine Drug: infliximab Drug: N-3 Polyunsaturated Fatty Acids	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 13, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

1 year postoperative anastomotic recurrence rate [1 year]
anastomotic recurrence including endoscopic recurrence and imaging recurrence

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.