Pre-operative Nutrition for Inflammatory Bowel Disease

Overseen By Jennifer Katz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: No IBD, Age < 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ensure Surgery Immunonutrition shakes for pre-operative nutrition in patients with Inflammatory Bowel Disease?

Research suggests that preoperative nutrition, including immunonutrition, can improve nutritional status and reduce complications in patients undergoing surgery for inflammatory bowel disease. While specific data on Ensure Surgery Immunonutrition shakes is not provided, similar treatments have shown benefits in reducing postoperative complications. ^{1 2 3 4 5}

Is pre-operative nutrition, like Ensure Surgery Immunonutrition shakes, safe for humans?

Pre-operative nutrition, including immunonutrition, is generally considered safe for humans and can improve nutritional status and reduce complications in patients undergoing surgery, especially those at risk of malnutrition. ^{1 2 3 4 5}

How does pre-operative nutrition differ from other treatments for inflammatory bowel disease?

Pre-operative nutrition for inflammatory bowel disease is unique because it focuses on improving nutritional status before surgery, which can reduce complications and disease severity. Unlike standard drug treatments, this approach uses oral or enteral nutrition (feeding through the digestive tract) and, in severe cases, parenteral nutrition (feeding through a vein) to address malnutrition, a common issue in IBD patients. ^{1 3 4 5 6}

Research Team

Jennifer Katz, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

Inclusion Criteria

Able and willing to provide written informed consent

I am scheduled for surgery on my intestines at NYU Langone Health for my condition.

I have been diagnosed with inflammatory bowel disease.

Exclusion Criteria

I am not fluent in English.

I do not have inflammatory bowel disease.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutrition Intervention

Participants receive nutrition-focused visits and interventions to mitigate malnutrition prior to surgery

Up to 30 days

1 visit (in-person), additional follow-ups as needed

Surgery and Immediate Post-operative Care

Participants undergo elective or emergent resection surgery and receive immediate post-operative care

Hospital stay up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of postoperative complications

30 days post-surgery

1 visit (in-person), phone calls for follow-up

Treatment Details

Interventions

• Ensure Surgery Immunonutrition shakes

Trial Overview 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.

Participant Groups

Group I: Nutrition specialist Experimental Treatment 2 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Perioperative Care of Patients with Inflammatory Bowel Disease: Focus on Nutritional Support. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Preoperative Nutritional Status on the Incidence Rate of Surgical Complications in Patients With Inflammatory Bowel Disease With Vs Without Preoperative Biologic Therapy: A Case-Control Study. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between Nutritional Screening Tools and GLIM in Complicated IBD Requiring Surgery. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Preoperative immunonutrition in patients at nutritional risk: results of a double-blinded randomized clinical trial. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Nutritional support of surgical patients with inflammatory bowel disease. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Nutritional Support of Patient with Inflammatory Bowel Disease. [2015]