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Pre-operative Nutrition for Inflammatory Bowel Disease
N/A
Waitlist Available
Led By Jennifer Katz, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week post surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using better tools to identify and treat malnutrition can reduce risks for patients undergoing surgery for inflammatory bowel disease. They also want to see if using a specific type of nutrition can
Who is the study for?
This trial is for patients with inflammatory bowel disease (IBD) who are scheduled for elective resection surgery. Participants should be screened for malnutrition and willing to follow a nutrition plan provided by specialists.
What is being tested?
The study tests if screening IBD patients for malnutrition and giving them special immune-boosting shakes before surgery can reduce post-surgery risks, shorten hospital stays, and lessen major complications.
What are the potential side effects?
Potential side effects from the Ensure Surgery Immunonutrition shakes may include gastrointestinal discomfort or allergic reactions. However, these shakes are generally well-tolerated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 3 (30 days post-surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 3 (30 days post-surgery)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Length of hospital stay
Proportion of patients who experienced postoperative major complications
Secondary study objectives
Percentage of nutritional shakes completed post-surgery
Percentage of nutritional shakes completed pre-surgery
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutrition specialistExperimental Treatment2 Interventions
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 II: Standard of CareActive Control1 Intervention
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,435 Total Patients Enrolled
Jennifer Katz, MDPrincipal InvestigatorNYU Langone Health
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