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

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ClinicalTrials.gov Identifier: NCT04014517
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Standard of Care Dietary Supplement: Immunonutrition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: Standard of Care
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
Other: Standard of Care
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

Experimental: Immunonutrition
Impact
Dietary Supplement: Immunonutrition
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 Measures :
  1. Post-operative infective complications rate [ Time Frame: 30 days post-operatively ]
    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

  2. 6 months endoscopic recurrence [ Time Frame: 6 months post-operatively ]
    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 :
  1. 6 months nutritional status [ Time Frame: 6 months post-operatively ]
    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.

  2. 30 days quality of life [ Time Frame: 30 days post-operatively ]
    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).

  3. 90 days quality of life [ Time Frame: 90 days post-operatively ]
    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).

  4. 6 months quality of life [ Time Frame: 6 months post-operatively ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014517


Contacts
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Contact: Annalisa Maroli, PhD +390282247776 annalisa.maroli@humanitas.it
Contact: Lara Monti, MS +390282244623 lara.monti@humanitas.it

Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Antonino Spinelli, MD, PhD Istituto Clinico Humanitas
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04014517    
Other Study ID Numbers: 2019-001
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Clinico Humanitas:
Inflammatory Bowel Diseases
Crohn's Disease
Immunonutrition
Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes