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

NCT03333148 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB -170222002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Colorectal Surgery; Immunonutrition; Complications; Microbiome; Preoperative nutrition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)

  Baseline (preoperative visit)

• Detection of the differences in the markers of inflammation 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)

  Baseline (preoperative visit) to postoperative day 3

• Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)

  Baseline (preoperative visit)

• Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)

  Baseline (preoperative visit) to day of surgery

Other Outcomes (8)

• Length of hospital stay (LOS)

  Baseline (Day of surgery) to day of discharge (approximately 2 to 30 days post surgery)

• Patient Quality of Life (QOL)

  Baseline (preoperative visit)

• Patient Quality of Life (QOL)

  Baseline (preoperative) to 30 days

Study Arms (2)

Arm A - Nestle IMPACT Immunonutrition

EXPERIMENTAL

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

Arm B- Standard of Care

OTHER

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

Other: Arm B- Standard of Care

Interventions

Nestle IMPACT Immunonutrition DRUG

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.

Also known as: Nestle IMPACT Advanced Recovery Immunonutrition

Arm A - Nestle IMPACT Immunonutrition

Arm B- Standard of Care OTHER

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

Also known as: Standard of Care

Arm B- Standard of Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Standard of Care

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

Study Officials

• Gregory D Kennedy, MD,PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 17, 2020

Record last verified: 2020-08