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Withdrawn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
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
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
NCT ID
NCT03333148
First Posted
October 20, 2017
Last Updated
August 13, 2020
Sponsor
University of Alabama at Birmingham
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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