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

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Polyunsaturated Acid Lipidosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
azathioprine
infliximab
N-3 Polyunsaturated Fatty Acids
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    n-3PUFA treatment group

    Conventional treatment group

    Arm Description

    On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 14, 2021
    Last Updated
    February 18, 2021
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04761952
    Brief Title
    N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease
    Official Title
    N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease：a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 13, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases, Crohn Disease, Polyunsaturated Acid Lipidosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    236 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    n-3PUFA treatment group
    Arm Type
    Experimental
    Arm Description
    On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative.
    Arm Title
    Conventional treatment group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    azathioprine
    Other Intervention Name(s)
    AZA
    Intervention Description
    daily orally
    Intervention Type
    Drug
    Intervention Name(s)
    infliximab
    Other Intervention Name(s)
    IFX
    Intervention Description
    intravenously, at 0, 2,6 weeks with every 8-week-interval later
    Intervention Type
    Drug
    Intervention Name(s)
    N-3 Polyunsaturated Fatty Acids
    Other Intervention Name(s)
    n-3PUFA
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    1 year postoperative anastomotic recurrence rate
    Description
    anastomotic recurrence including endoscopic recurrence and imaging recurrence
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    3 months postoperative anastomotic recurrence rate
    Description
    anastomotic recurrence including endoscopic recurrence and imaging recurrence
    Time Frame
    3 months
    Title
    clinical recurrence rate
    Description
    CDAI score larger than 150
    Time Frame
    3 months，1 year
    Title
    Inflammatory load
    Description
    level of serum C- reactive protein
    Time Frame
    3 months，1 year
    Title
    Inflammatory load
    Description
    level of serum fecal calprotectin
    Time Frame
    3 months，1 year
    Title
    Life quality SF-36
    Description
    inflammatory bowel disease questionnaire and health survey summary table SF-36
    Time Frame
    3 months，1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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

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