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

NCT04761952 | Unknown

• 1 other identifier: 2020ZSLYEC-292
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 1 year postoperative anastomotic recurrence rate

  anastomotic recurrence including endoscopic recurrence and imaging recurrence

  1 year

Secondary Outcomes (5)

• 3 months postoperative anastomotic recurrence rate

  3 months

• clinical recurrence rate

  3 months，1 year

• Inflammatory load

  3 months，1 year

• Inflammatory load

  3 months，1 year

• Life quality SF-36

  3 months，1 year

Study Arms (2)

n-3PUFA treatment group

EXPERIMENTAL

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; Drug: infliximab; Drug: N-3 Polyunsaturated Fatty Acids

Conventional treatment group

PLACEBO COMPARATOR

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; Drug: infliximab

Interventions

azathioprine DRUG

daily orally

Also known as: AZA

Conventional treatment group; n-3PUFA treatment group

infliximab DRUG

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

Also known as: IFX

Conventional treatment group; n-3PUFA treatment group

N-3 Polyunsaturated Fatty Acids 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.

Also known as: n-3PUFA

n-3PUFA treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Neuronal Ceroid-Lipofuscinoses

Interventions

Azathioprine; Infliximab; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 21, 2021
• Study Start: February 13, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 21, 2021

Record last verified: 2021-02