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

NCT03333148 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-08-17

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Nestle IMPACT Immunonutrition

Along with standard of care nutritional therapy patients (n=146) will be asked to consume 3 cartons/day for 14 days of Nestle IMPACT Advanced Recovery Immunonutrition.

OTHER

Arm B- Standard of Care

No intervention standard of care nutrition (n=146).

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Gregory D Kennedy, MD,PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-01
Completion
2022-01-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333148 on ClinicalTrials.gov