Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT)

• Status: Withdrawn
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The central focus of this trial is to understand the effectiveness of Preoperative Immunonutrition (PINT) in improving surgical outcomes for patients with inflammatory bowel disease (IBD). We hypothesize that PINT will reduce post-operative complications in IBD patients undergoing elective surgery with added improvements in length-of-stay (LOS), quality of life (QOL) and patient satisfaction. As a secondary focus, the investigator will aim to better understand the potential mechanism-of-action by which PINT may have its effects through analyses of biomarkers including inflammatory markers, nutritional proteins and the fecal microbiome.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

• ≥19 years of age

• All races and all genders

• Confirmed diagnosis and history of IBD

• ESPEN Nutritional Risk Scores >=3 and the ESPEN Disease Severity sub-score < 3

• Scheduled for elective surgery via any transabdominal operative approach (i.e. laparoscopic, hand-assisted, robotic, open) with a planned postoperative inpatient stay of at least one night

Exclusion Criteria:

• Failure to meet eligibility criteria

• Patients requiring emergency surgical intervention

• Patients with an American Society of Anesthesiologist physical status of IV or V

• Patients requiring hemodialysis

• Patients with history of myocardial infarction within 6 months

• Patients with a history of asthma

• Patients with cirrhosis or a history of liver disease

• Patients with a present history of dysphagia, pyloric stenosis and esophageal strictures

• Patients unable to consume liquids orally

• Patients allergic or with hypersensitivity reactions to any of the components of the Nestlé IMPACT-Advanced Recovery immunonutritional supplement

• Patients with a history of galactosemia, the inability to metabolize the sugar galactose appropriately

• Patients with bowel obstructions

• Patients with history of HIV or of solid-organ transplant

• Patients who are pregnant or breastfeeding