Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease

NCT ID: NCT06309017

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutrition specialist

Intervention Type: OTHER

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

Ensure Surgery Immunonutrition shakes

Intervention Type: DIETARY_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.

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.

Group Type: ACTIVE_COMPARATOR

Ensure Surgery Immunonutrition shakes

Intervention Type: DIETARY_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.

Interventions

Nutrition specialist

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

Intervention Type: OTHER

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Katz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Katz, MD

Role: CONTACT

Jennifer.katz@nyulangone.org

(855) 698-4232

Other Identifiers

23-01243

Identifier Type: -

Identifier Source: org_study_id