Inflammatory Bowel DiseasesNCT06309017
Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
A study testing Nutrition specialist and Ensure Surgery Immunonutrition shakes in people with Inflammatory Bowel Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Nutrition specialist and Ensure Surgery Immunonutrition shakes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Aged 18 years of age or older
- Confirmed diagnosis of inflammatory bowel disease
- Scheduled for disease-related intestinal resection at NYU Langone Health
Who cannot join
- No current diagnosis of inflammatory bowel disease
- Age less than 18
- Not proficient (able to read and answer questions) in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Nutrition specialist, Ensure Surgery Immunonutrition shakes
- 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.
Nutrition specialistOther
Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.
Ensure Surgery Immunonutrition shakesDietary supplement
All study subjects, including subjects without malnutrition, will be given the Ensure Surgery Immunonutrition Shakes for prior to surgery as per standard of care. All subjects will also receive additional shakes starting as an inpatient when diet is advanced.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition specialist | Experimental | Participants will be assigned to this arm if the subject is determined malnourished. They will be sent to a nutrition specialist for a nutrition focused visit and will be provided standard of care intervention prior surgery. Receives: Other: Nutrition specialist; Dietary Supplement: Ensure Surgery Immunonutrition shakes |
| Standard of Care | Active comparator | Participants that show no signs of malnutrition will be assigned to this arm. The subject will be provided with education and schedule of Ensure® Surgery Immunonutrition shakes for prior to surgery as per standard of care. Receives: Dietary Supplement: Ensure Surgery Immunonutrition shakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
From the time the patient is admitted at hospital for surgery until the patient is discharged.
Measured: Up to 30 days post-surgery
Proportion of patients who experienced postoperative major complications
Major complications include infection, bleeding (requiring blood transfusion or requiring intervention), cardiac event (myocardial infarction, arrhythmia, and cardiac arrest), stroke, acute kidney injury (increase in serum creatinine of ≥0.3 mg/dL from baseline or ≥1.5 times baseline), venous thromboembolism, reoperation, readmission, and need for ICU-level care. The outcome measure will be obtained from the electronic health record (EHR).
Measured: Visit 3 (30 days post-surgery)
Secondary outcomes (8)
Proportion of patients who participated in a nutritional intervention program before surgery
Measured: Visit 3 (30 days post-surgery)
Proportion of patients who participated in a nutritional intervention program after surgery
Measured: Visit 3 (30 days post-surgery)
Number of nutritional shakes completed
Measured: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed overall
Measured: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed pre-surgery
Subject will be called the day prior to surgery to determine the number of shakes consumed by patient.
Measured: One day prior to surgery
Percentage of nutritional shakes completed post-surgery
One week after surgery, a phone call will follow to determine how many shakes subject consumed.
Measured: One week post surgery
Proportion of patients who experienced any postoperative complications
Measured: Visit 3 (30 days post-surgery)
Proportion of patients with 30 day readmission
Measured: Up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start7 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
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 NYU Langone HealthThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Katz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309017
- Sponsor's protocol ID
- 23-01243
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Jennifer.katz@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06309017
- Acronym / sponsor ID
- 23-01243
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Mar 2024 (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.
This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition specialist | Experimental | Other: Nutrition specialist, Dietary Supplement: Ensure Surgery Immunonutrition shakesParticipants will be assigned to this arm if the subject is determined malnourished. They will be sent to a nutrition specialist for a nutrition focused visit and will be provided standard of care intervention prior surgery. |
| Standard of Care | Active comparator | Dietary Supplement: Ensure Surgery Immunonutrition shakesParticipants that show no signs of malnutrition will be assigned to this arm. The subject will be provided with education and schedule of Ensure® Surgery Immunonutrition shakes for prior to surgery as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide written informed consent
- Aged 18 years of age or older
- Confirmed diagnosis of inflammatory bowel disease
- Scheduled for disease-related intestinal resection at NYU Langone Health
Key exclusion criteria (3 listed)
- No current diagnosis of inflammatory bowel disease
- Age less than 18
- Not proficient (able to read and answer questions) in English
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 |
|---|---|---|
| Nutrition specialistNutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition. | Other | Nutrition specialist |
| Ensure Surgery Immunonutrition shakesAll study subjects, including subjects without malnutrition, will be given the Ensure Surgery Immunonutrition Shakes for prior to surgery as per standard of care. All subjects will also receive additional shakes starting as an inpatient when diet is advanced. | Dietary supplement | Nutrition specialist, Standard of Care |
Primary outcome
Length of hospital stay
Time frame: Up to 30 days post-surgery
From the time the patient is admitted at hospital for surgery until the patient is discharged.
Proportion of patients who experienced postoperative major complications
Time frame: Visit 3 (30 days post-surgery)
Major complications include infection, bleeding (requiring blood transfusion or requiring intervention), cardiac event (myocardial infarction, arrhythmia, and cardiac arrest), stroke, acute kidney injury (increase in serum creatinine of ≥0.3 mg/dL from baseline or ≥1.5 times baseline), venous thromboembolism, reoperation, readmission, and need for ICU-level care. The outcome measure will be obtained from the electronic health record (EHR).
8 secondary outcomes
Proportion of patients who participated in a nutritional intervention program before surgery
Time frame: Visit 3 (30 days post-surgery)
Proportion of patients who participated in a nutritional intervention program after surgery
Time frame: Visit 3 (30 days post-surgery)
Number of nutritional shakes completed
Time frame: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed overall
Time frame: Visit 3 (30 days post-surgery)
Percentage of nutritional shakes completed pre-surgery
Time frame: One day prior to surgery
Percentage of nutritional shakes completed post-surgery
Time frame: One week post surgery
Proportion of patients who experienced any postoperative complications
Time frame: Visit 3 (30 days post-surgery)
Proportion of patients with 30 day readmission
Time frame: Up to 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Jennifer.katz@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Jennifer Katz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition specialist and Ensure Surgery Immunonutrition shakes in people with Inflammatory Bowel Diseases, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Katz, MD ((855) 698-4232, Jennifer.katz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Up to 30 days post-surgery). The study lists 2 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 5 Mar 2026.