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

Study Overview
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Brief Summary
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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.

Detailed Description
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Inflammatory bowel disease (IBD), which includes Crohn's and Ulcerative Colitis, is a chronic and costly disease of unknown etiology that now affects over 3.1 million people in the United States. Patients with IBD suffer from lifelong malnutrition, pain and bleeding with added risks of cancers, obstructions and fistulas. There is no known cure and the incidence continues to grow. While treatments are usually medical IBD patients will undergo at least one major surgery during their lifetime. Patients also have particularly poor surgical outcomes with high rates of post-operative complications. In an attempt to improve the risk profile of patients and decrease complications, preoperative total parenteral nutrition (TPN) has been used to optimize IBD patients for surgery. While this approach has been successful the cost and morbidities of TPN prohibit its generalized application. Practical strategies that improve surgical outcomes for IBD patients are urgently needed. Improving nutritional deficiencies before an operation may be a practical way to improve post-operative outcomes. The oral administration of preoperative immunonutrition, is an alternative method to improve nutritional states and may have utility in IBD patients who have particularly severe nutritional deficiencies because of disease-specific issues in malabsorption, maldigestion and loss of appetite.

Official Title
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Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: Nestle IMPACT Immunonutrition
* Other: Arm B- Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - Nestle IMPACT Immunonutrition<br>Treatment Arm A (n=146) - Nestlé IMPACT Advanced Recovery:Along with standard of care nutritional therapy patients will be asked to consume 3 cartons/day for 14 days of Nestle IMPACT Advanced Recovery Immunonutrition. | Drug: Nestle IMPACT Immunonutrition<br>* 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.<br>* Other names: Nestle IMPACT Advanced Recovery Immunonutrition;|
| Other: Arm B- Standard of Care<br>No intervention standard of care nutrition (n=146). | Other: Arm B- Standard of Care<br>* No intervention standard of care nutrition (n=146).<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of any postoperative complications after surgery | Routine postoperative follow-up for all patients will occur at 2 weeks post discharge. Any serious adverse events or adverse events will be ascertained at the 2 week follow up visit. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major. | Baseline (day of surgery) to 2 weeks (after surgery) | 
| The occurrence of any postoperative complications after surgery | At the 30 day post-discharge postoperative follow up visit, serious adverse events will be ascertained that may have occurred after the 2 week follow up visit. Patients who are unable to return on the 30-day mark will be called to screen for any post-discharge complications. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major. | Baseline (day of surgery) to 30 days (after surgery) | 
| The occurrence of any postoperative complications after surgery | Final call to ascertain complications will be at 60 days. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major. | Baseline (day of surgery) to 60 days (after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β. | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β. | Baseline (preoperative visit) to day of surgery | 
| Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β. | Baseline (preoperative visit) to postoperative day 3 | 
| Detection of the differences in the markers of inflammation Interleukin 6 (IL-6) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6). | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation Interleukin 6 (IL-6) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6). | Baseline (preoperative visit) to day of surgery | 
| Detection of the differences in the markers of inflammation Interleukin 6 (IL-6) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6). | Baseline (preoperative visit) to postoperative day 3 | 
| Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α). | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α). | Baseline to day of surgery | 
| Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α). | Baseline (preoperative visit) to postoperative day 3 | 
| Detection of the differences in the markers of inflammation CRP | Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels. | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation CRP | Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels. | Baseline (preoperative visit) to day of surgery | 
| Detection of the differences in the markers of inflammation CRP | Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels. | Baseline (preoperative visit) to postoperative day 3 | 
| Detection of the differences in the markers of inflammation nutritional status albumin | Comprehensive metabolic panels will be ordered to assess levels of serum albumin | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation nutritional status albumin | Comprehensive metabolic panels will be ordered to assess levels of serum albumin | Baseline (preoperative visit) to day of surgery | 
| Detection of the differences in the markers of inflammation nutritional status albumin | Comprehensive metabolic panels will be ordered to assess levels of serum albumin | Baseline (preoperative visit) to postoperative day 3 | 
| Detection of the differences in the markers of inflammation pre-albumin | Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin | Baseline (preoperative visit) | 
| Detection of the differences in the markers of inflammation pre-albumin | Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin | Baseline (preoperative visit) to day of surgery | 
| Detection of the differences in the markers of inflammation pre-albumin | Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin | Baseline (preoperative visit) to postoperative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery, Immunonutrition, Complications, Microbiome, Preoperative nutrition