150 Participants Needed

Pre-operative Nutrition for Inflammatory Bowel Disease

JK
Overseen ByJennifer Katz, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pre-surgery nutrition might aid recovery in people with inflammatory bowel disease (IBD). Researchers aim to determine if identifying and treating malnutrition can reduce post-surgery complications. They are also testing whether Ensure Surgery Immunonutrition shakes can enhance recovery. Participants with IBD scheduled for intestinal surgery at NYU Langone Health, who can communicate in English and provide consent, may be eligible.

As an unphased trial, this study allows participants to contribute to important research that could enhance surgical recovery for future IBD patients.

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 prior data suggests that Ensure Surgery Immunonutrition shakes are safe for pre-operative use in IBD patients?

Research has shown that Ensure Surgery Immunonutrition shakes are designed to aid recovery and boost the immune system, particularly around surgery. These shakes contain essential nutrients, including high-quality protein, which supports tissue repair and healing. Some individuals have experienced side effects like gas and stomach issues when consuming these shakes. It is important to use them under a doctor's guidance to monitor and manage any side effects. Although specific data on negative effects is lacking, the shakes are generally considered safe. Approval for another condition suggests they are trusted to be safe.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Ensure Surgery Immunonutrition shakes for pre-operative nutrition in inflammatory bowel disease because they offer a targeted approach to improving surgical outcomes. Unlike standard treatments that primarily focus on managing inflammation with medication, these shakes are designed to enhance the body's immune response and nutritional status before surgery. This nutritional boost can potentially lead to better recovery times and reduced complications, offering a complementary strategy to traditional medical therapies.

What evidence suggests that this trial's treatments could be effective for inflammatory bowel disease?

Research suggests that special nutrition before surgery, such as immunonutrition, can improve health and reduce complications for patients. Studies have shown that drinking immunonutrition shakes before surgery helps the bowel recover faster. This nutrition may also lower the risk of post-surgery problems. Some research found that it can even reduce the time patients spend in the hospital. While larger studies are needed, evidence indicates that these nutritional shakes can aid recovery for people with inflammatory bowel disease (IBD). Participants in this trial will either receive a standard of care intervention with Ensure® Surgery Immunonutrition shakes or be referred to a nutrition specialist if found to be malnourished.56789

Who Is on the Research Team?

JK

Jennifer Katz, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutrition specialistExperimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Pre-operative Nutrition for Inflammatory Bowel DiseaseResearch suggests that preoperative nutrition, including immunonutrition, can improve nutritional status and reduce complications in patients undergoing surgery ...
Effects of preoperative immunonutrition vs standard oral ...The observations suggested that earlier bowel return was enhanced by preoperative immunonutrition consumption. In this study, the clinical ...
Effect of Perioperative Nutritional Supplementation on ...Perioperative carbohydrate loading, increased protein intake, and immunonutrition may decrease postoperative complications. Studies on the topic have led to ...
Pre-Surgery Nutrition Support May Cut Hospital Stays for ...Investigators concluded that pre-surgery nutrition support may cut hospital stays for patients with IBD, but bigger studies are needed.
Inflammatory bowel disease (IBD): Using nutrition to improve ...Nutrition recommendations may include a light meal, shakes (including immunonutrition types), and ideas for hydration. These can help reduce nausea or upset ...
Ensure® SurgeryImmunonutrition shake. ENSURE SURGERY is specially designed to support immune health and recovery from surgery. For oral use. Use under medical supervision.
Ensure® Surgery Drink | Liquid Diet After ...The vanilla taste is just fine. However, the shake itself messes with my stomach/bowels, since day one of drinking the shakes, I've had extreme gas, stomach ...
Ensure Surgery Immunonutrition Shake / Vanilla / 8 fl oz ...Ensure Surgery immunonutrition shake contains 18 grams of high-quality protein to support tissue repair and wound healing. It also has EPA & DHA (omega-3 fatty ...
Ensure® Surgery Drink | Liquid Diet After ...Learn about Ensure Surgery Immunonutrition vanilla shake, specially designed to support immune health and recovery when added to your diet after surgery.
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