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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Crohn Disease

Treatments: Other: Standard of Care; Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04014517

2019-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Standard of Care

Active Comparator group

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

Treatment:

Other: Standard of Care

Immunonutrition

Experimental group

Description:

Impact

Treatment:

Dietary Supplement: Immunonutrition