Inflammatory Bowel DiseasesEarly Phase 1PINTNCT03333148
Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT)
A Early Phase 1 study testing Nestle IMPACT Immunonutrition in people with Inflammatory Bowel Diseases, run by University of Alabama at Birmingham.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Nestle IMPACT Immunonutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Nestle IMPACT Immunonutrition, Arm B- Standard of Care
- Keywords
- Colorectal Surgery, Immunonutrition, Complications, Microbiome, Preoperative nutrition
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestle IMPACT ImmunonutritionDrug
Also called Nestle IMPACT Advanced Recovery Immunonutrition
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.
Arm B- Standard of CareOther
Also called Standard of Care
No intervention standard of care nutrition (n=146).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nestle IMPACT Immunonutrition |
| Arm B- Standard of Care | Other | No intervention standard of care nutrition (n=146). Receives: Other: Arm B- Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (preoperative visit) to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: never enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory D. Kennedy, University of Alabama at Birmingham
- Investigators
- Gregory D Kennedy, MD,PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333148
- Sponsor's protocol ID
- IRB -170222002
- Acronym
- PINT
- Status last verified
- Aug 2020
- First submitted
- 20 Oct 2017
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03333148
- Acronym / sponsor ID
- PINT / IRB -170222002
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Colorectal Surgery, Immunonutrition, Complications, Microbiome, Preoperative nutrition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Nestle IMPACT Immunonutrition | Experimental | Drug: Nestle IMPACT ImmunonutritionTreatment 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 B- Standard of Care | Other | Other: Arm B- Standard of CareNo intervention standard of care nutrition (n=146). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nestle IMPACT ImmunonutritionAlso: Nestle IMPACT Advanced Recovery ImmunonutritionAlong 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. | Drug | Arm A - Nestle IMPACT Immunonutrition |
| Arm B- Standard of CareAlso: Standard of CareNo intervention standard of care nutrition (n=146). | Other | Arm B- Standard of Care |
Primary outcome
The occurrence of any postoperative complications after surgery
Time frame: Baseline (day of surgery) to 2 weeks (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
Time frame: Baseline (day of surgery) to 30 days (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
Time frame: Baseline (day of surgery) to 60 days (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.
18 secondary outcomes
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Time frame: Baseline to day of surgery
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation CRP
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation CRP
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation CRP
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation nutritional status albumin
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation nutritional status albumin
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation nutritional status albumin
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation pre-albumin
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation pre-albumin
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation pre-albumin
Time frame: Baseline (preoperative visit) to postoperative day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Kennedy, MD,PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nestle IMPACT Immunonutrition in people with Inflammatory Bowel Diseases, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of any postoperative complications after surgery (time frame: Baseline (day of surgery) to 2 weeks (after surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.