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

NCT04014517 | Unknown

• 1 other identifier: 2019-001
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Diseases; Crohn's Disease; Immunonutrition

Outcome Measures

Primary Outcomes (2)

• 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

  30 days post-operatively

• 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).

  6 months post-operatively

Secondary Outcomes (4)

• 6 months nutritional status

  6 months post-operatively

• 30 days quality of life

  30 days post-operatively

• 90 days quality of life

  90 days post-operatively

• 6 months quality of life

  6 months post-operatively

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Immunonutrition

EXPERIMENTAL

Impact

Dietary Supplement: Immunonutrition

Interventions

Standard of Care OTHER

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

Standard of Care

Immunonutrition DIETARY_SUPPLEMENT

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

Immunonutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Standard of Care; Immunonutrition Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonino Spinelli, MD, PhD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

+390282247776; annalisa.maroli@humanitas.it

Lara Monti, MS

CONTACT

+390282244623; lara.monti@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share