search
Back to results

Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients (EPIRIC)

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard of Care
Immunonutrition
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring Inflammatory Bowel Diseases, Crohn's Disease, Immunonutrition

Eligibility Criteria

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

Inclusion Criteria:

  • Patients > 18 years old, females or males;
  • Established Crohn's Disease at the time of surgery indication;
  • Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
  • Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.

Exclusion Criteria:

  • Patients < 18 years old;
  • Pregnant or breastfeeding women;
  • Diagnosis of undetermined colitis;
  • Concomitant diagnosis of malignancy;
  • Established malnutrition, according to clinical definition, requiring nutritional intervention;
  • Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
  • Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
  • Patients known to have allergic history to any component of the investigational product;
  • Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
  • Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
  • Planned recovery shorter than 48 hours;
  • Surgery in emergency setting;
  • Any concomitant surgery not related to CD or perianal CD.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard of Care

    Immunonutrition

    Arm Description

    Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist

    Impact

    Outcomes

    Primary Outcome Measures

    Post-operative infective complications rate
    Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
    6 months endoscopic recurrence
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score. Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).

    Secondary Outcome Measures

    6 months nutritional status
    Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST). MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.
    30 days quality of life
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
    90 days quality of life
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
    6 months quality of life
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).

    Full Information

    First Posted
    July 8, 2019
    Last Updated
    November 25, 2019
    Sponsor
    Istituto Clinico Humanitas
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04014517
    Brief Title
    Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
    Acronym
    EPIRIC
    Official Title
    Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Clinico Humanitas

    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
    This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.
    Detailed Description
    Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease
    Keywords
    Inflammatory Bowel Diseases, Crohn's Disease, Immunonutrition

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
    Arm Title
    Immunonutrition
    Arm Type
    Experimental
    Arm Description
    Impact
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Immunonutrition
    Intervention Description
    Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days
    Primary Outcome Measure Information:
    Title
    Post-operative infective complications rate
    Description
    Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
    Time Frame
    30 days post-operatively
    Title
    6 months endoscopic recurrence
    Description
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score. Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).
    Time Frame
    6 months post-operatively
    Secondary Outcome Measure Information:
    Title
    6 months nutritional status
    Description
    Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST). MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.
    Time Frame
    6 months post-operatively
    Title
    30 days quality of life
    Description
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
    Time Frame
    30 days post-operatively
    Title
    90 days quality of life
    Description
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
    Time Frame
    90 days post-operatively
    Title
    6 months quality of life
    Description
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
    Time Frame
    6 months post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients > 18 years old, females or males; Established Crohn's Disease at the time of surgery indication; Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty; Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study. Exclusion Criteria: Patients < 18 years old; Pregnant or breastfeeding women; Diagnosis of undetermined colitis; Concomitant diagnosis of malignancy; Established malnutrition, according to clinical definition, requiring nutritional intervention; Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking; Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial; Patients known to have allergic history to any component of the investigational product; Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal); Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L; Planned recovery shorter than 48 hours; Surgery in emergency setting; Any concomitant surgery not related to CD or perianal CD.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Annalisa Maroli, PhD
    Phone
    +390282247776
    Email
    annalisa.maroli@humanitas.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lara Monti, MS
    Phone
    +390282244623
    Email
    lara.monti@humanitas.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonino Spinelli, MD, PhD
    Organizational Affiliation
    Istituto Clinico Humanitas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients

    We'll reach out to this number within 24 hrs