Inflammatory Bowel Diseases Clinical Trial
— PINTOfficial title:
Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial
Verified date | August 2020 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2022 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Alabama at Birmingham |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of hospital stay (LOS) | Length of stay will be captured through patient hospitalization files | Baseline (Day of surgery) to day of discharge (approximately 2 to 30 days post surgery) | |
Other | Patient Quality of Life (QOL) | 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. | Baseline (preoperative visit) | |
Other | Patient Quality of Life (QOL) | 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. | Baseline (preoperative) to 30 days | |
Other | Patient Satisfaction (S-CAHPS) | 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. | Baseline (Preoperative) | |
Other | Patient Satisfaction (S-CAHPS) | 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. | Postoperative (After Surgery) | |
Other | Detection of differences in fecal microbiome | 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. | Baseline (Preoperative) | |
Other | Detection of differences in fecal microbiome | 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. | Day of Surgery | |
Other | Detection of differences in fecal microbiome | 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. | 2 weeks after surgery (postoperative visit) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Detection of the differences in the markers of inflammation interleukin-1-ß (IL-1ß) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-ß (IL-1ß. | Baseline (preoperative visit) | |
Secondary | Detection of the differences in the markers of inflammation interleukin-1-ß (IL-1ß) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-ß (IL-1ß. | Baseline (preoperative visit) to day of surgery | |
Secondary | Detection of the differences in the markers of inflammation interleukin-1-ß (IL-1ß) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-ß (IL-1ß. | Baseline (preoperative visit) to postoperative day 3 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-a) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-a). | Baseline (preoperative visit) | |
Secondary | Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-a) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-a). | Baseline to day of surgery | |
Secondary | Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-a) | Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-a). | Baseline (preoperative visit) to postoperative day 3 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 |
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