Recruiting

Pre-operative Nutrition

Sponsor:

NYU Langone Health

Code:

NCT06309017

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nutrition specialist

Ensure Surgery Immunonutrition shakes

Study Details

Brief 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. 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

Study ID

NCT06309017

Start date

Jan 7, 2025

Status verified date

Mar, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able and willing to provide written informed consent
2. Aged 18 years of age or older
3. Confirmed diagnosis of inflammatory bowel disease
4. Scheduled for disease-related intestinal resection at NYU Langone Health

Exclusion Criteria:

1. No current diagnosis of inflammatory bowel disease
2. Age less than 18
3. Not proficient (able to read and answer questions) in English

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nutrition specialist

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.

active comparator: Standard of Care

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.

Interventions

Nutrition specialist

Nutrition specialist to help improve nutritional status by diet, oral nutrition supplements or parenteral nutrition.

Ensure Surgery Immunonutrition shakes

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.

Primary outcome measure

  • Length of hospital stay [ Time Frame: Up to 30 days post-surgery ]
  • Proportion of patients who experienced postoperative major complications [ Time Frame: Visit 3 (30 days post-surgery) ]

Central Contacts and Locations

Central contacts

Jennifer Katz, MD

(855) 698-4232Jennifer.katz@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-05.