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

Primary Purpose

Inflammatory Bowel Diseases

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Nestle IMPACT Immunonutrition
Arm B- Standard of Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring Colorectal Surgery, Immunonutrition, Complications, Microbiome, Preoperative nutrition

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Arm A - Nestle IMPACT Immunonutrition

    Arm B- Standard of Care

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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).
    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).
    Detection of the differences in the markers of inflammation CRP
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Detection of the differences in the markers of inflammation CRP
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Detection of the differences in the markers of inflammation CRP
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Detection of the differences in the markers of inflammation nutritional status albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Detection of the differences in the markers of inflammation nutritional status albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Detection of the differences in the markers of inflammation nutritional status albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Detection of the differences in the markers of inflammation pre-albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
    Detection of the differences in the markers of inflammation pre-albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
    Detection of the differences in the markers of inflammation pre-albumin
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin

    Full Information

    First Posted
    October 20, 2017
    Last Updated
    August 13, 2020
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03333148
    Brief Title
    Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT)
    Acronym
    PINT
    Official Title
    Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    never enrolled
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases
    Keywords
    Colorectal Surgery, Immunonutrition, Complications, Microbiome, Preoperative nutrition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A - Nestle IMPACT Immunonutrition
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Arm B- Standard of Care
    Arm Type
    Other
    Arm Description
    No intervention standard of care nutrition (n=146).
    Intervention Type
    Drug
    Intervention Name(s)
    Nestle IMPACT Immunonutrition
    Other Intervention Name(s)
    Nestle IMPACT Advanced Recovery Immunonutrition
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Arm B- Standard of Care
    Other Intervention Name(s)
    Standard of Care
    Intervention Description
    No intervention standard of care nutrition (n=146).
    Primary Outcome Measure Information:
    Title
    The occurrence of any postoperative complications after surgery
    Description
    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.
    Time Frame
    Baseline (day of surgery) to 2 weeks (after surgery)
    Title
    The occurrence of any postoperative complications after surgery
    Description
    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.
    Time Frame
    Baseline (day of surgery) to 30 days (after surgery)
    Title
    The occurrence of any postoperative complications after surgery
    Description
    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.
    Time Frame
    Baseline (day of surgery) to 60 days (after surgery)
    Secondary Outcome Measure Information:
    Title
    Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
    Description
    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.
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
    Description
    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.
    Time Frame
    Baseline (preoperative visit) to day of surgery
    Title
    Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
    Description
    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.
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Title
    Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
    Time Frame
    Baseline (preoperative visit) to day of surgery
    Title
    Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Title
    Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
    Time Frame
    Baseline to day of surgery
    Title
    Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
    Description
    Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Title
    Detection of the differences in the markers of inflammation CRP
    Description
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation CRP
    Description
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Time Frame
    Baseline (preoperative visit) to day of surgery
    Title
    Detection of the differences in the markers of inflammation CRP
    Description
    Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Title
    Detection of the differences in the markers of inflammation nutritional status albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation nutritional status albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Time Frame
    Baseline (preoperative visit) to day of surgery
    Title
    Detection of the differences in the markers of inflammation nutritional status albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum albumin
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Title
    Detection of the differences in the markers of inflammation pre-albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
    Time Frame
    Baseline (preoperative visit)
    Title
    Detection of the differences in the markers of inflammation pre-albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
    Time Frame
    Baseline (preoperative visit) to day of surgery
    Title
    Detection of the differences in the markers of inflammation pre-albumin
    Description
    Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
    Time Frame
    Baseline (preoperative visit) to postoperative day 3
    Other Pre-specified Outcome Measures:
    Title
    Length of hospital stay (LOS)
    Description
    Length of stay will be captured through patient hospitalization files
    Time Frame
    Baseline (Day of surgery) to day of discharge (approximately 2 to 30 days post surgery)
    Title
    Patient Quality of Life (QOL)
    Description
    At the time of the pre-operative visit, following enrollment in the study, participants will complete the Health Related Quality of Life Survey SF-12 questionnaire (HRQoL SF-12). The results of the Health Related Quality of Life Survey SF-12 questionnaire (HRQoL SF-12) will be analyzed and Physical and Mental Health Composite Scores (PCS & MCS) will be computed using the scores of the twelve questions ranging from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
    Time Frame
    Baseline (preoperative visit)
    Title
    Patient Quality of Life (QOL)
    Description
    Patients at their two week follow up postoperative visit will be given another copy of the HRQoL SF-12 and prepaid return envelopes to be completed and mailed back two weeks after follow up Patients will receive a reminder call to complete the surveys and return in the mail. The results of the Health Related Quality of Life Survey SF-12 questionnaire (HRQoL SF-12) will be analyzed and Physical and Mental Health Composite Scores (PCS & MCS) will be computed using the scores of the twelve questions ranging from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
    Time Frame
    Baseline (preoperative) to 30 days
    Title
    Patient Satisfaction (S-CAHPS)
    Description
    Will be captured preoperatively with the S-CAHPS. Participants will be asked to complete the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) Survey. The S-CAHPS Surgical Care Survey was developed in 2009 through collaboration of the CAHPS consortium, American College of Surgeons (ACS), the Surgical Quality Alliance (SQA), the American Urological Association (AUA), 11 other surgical subspecialty groups and endorsed by the National Quality Forum (NQF) in 2012. The S-CAHPS is a 47 question survey that addresses patients' preoperative and postoperative experience with surgical care. The CAHPS Surgical Care Survey generates a global rating item, which uses a scale of 0 to 10 to measure respondents' assessments of their surgeon and composite measures (also known as reporting composites), which combine results for closely-related items that have been grouped together.
    Time Frame
    Baseline (Preoperative)
    Title
    Patient Satisfaction (S-CAHPS)
    Description
    Will be captured postoperatively with the S-CAHPS. Participants will be asked to complete the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) Survey. The S-CAHPS Surgical Care Survey was developed in 2009 through collaboration of the CAHPS consortium, American College of Surgeons (ACS), the Surgical Quality Alliance (SQA), the American Urological Association (AUA), 11 other surgical subspecialty groups and endorsed by the National Quality Forum (NQF) in 2012. The S-CAHPS is a 47 question survey that addresses patients' preoperative and postoperative experience with surgical care. The CAHPS Surgical Care Survey generates a global rating item, which uses a scale of 0 to 10 to measure respondents' assessments of their surgeon and composite measures (also known as reporting composites), which combine results for closely-related items that have been grouped together.
    Time Frame
    Postoperative (After Surgery)
    Title
    Detection of differences in fecal microbiome
    Description
    For fecal microbiome analyses, stool will be processed for 16S rRNA sequencing. DNA will be extracted from stool samples using the Fecal DNA Isolation Kit (Zymo Research, Irvine, CA) and processed with PCR amplification on the MiSeq. QIIME and UniFrac will be used to generate a comparative profile of microbial composition. QIIME will be used to assess taxa, alpha and beta diversity. Composition of the microbiome will be compared using UniFrac, Mothur and Genboree to assess for differences between microbiome populations by principal components analysis.
    Time Frame
    Baseline (Preoperative)
    Title
    Detection of differences in fecal microbiome
    Description
    For fecal microbiome analyses, stool will be processed for 16S rRNA sequencing. DNA will be extracted from stool samples using the Fecal DNA Isolation Kit (Zymo Research, Irvine, CA) and processed with PCR amplification on the MiSeq. QIIME and UniFrac will be used to generate a comparative profile of microbial composition. QIIME will be used to assess taxa, alpha and beta diversity. Composition of the microbiome will be compared using UniFrac, Mothur and Genboree to assess for differences between microbiome populations by principal components analysis.
    Time Frame
    Day of Surgery
    Title
    Detection of differences in fecal microbiome
    Description
    For fecal microbiome analyses, stool will be processed for 16S rRNA sequencing. DNA will be extracted from stool samples using the Fecal DNA Isolation Kit (Zymo Research, Irvine, CA) and processed with PCR amplification on the MiSeq. QIIME and UniFrac will be used to generate a comparative profile of microbial composition. QIIME will be used to assess taxa, alpha and beta diversity. Composition of the microbiome will be compared using UniFrac, Mothur and Genboree to assess for differences between microbiome populations by principal components analysis.
    Time Frame
    2 weeks after surgery (postoperative visit)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory D Kennedy, MD,PhD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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