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

NCT04761952 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2021-02-21

No results posted yet for this study

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

Interventions

DRUG

azathioprine

daily orally

DRUG

infliximab

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

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.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-13
Primary Completion
2022-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04761952 on ClinicalTrials.gov