Nutritional Supplementation for Lung Transplant Complications

Overseen By Judi Willhide, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Galactosemia, Milk allergy, Soy allergy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Pre-transplant period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the protein-rich nutritional shake, Ensure Enlive, can help individuals awaiting a lung transplant by reducing muscle loss and improving nutrition. The goal is to determine if this simple supplement can serve as a cost-effective method to combat malnutrition, which may lead to poor outcomes after a transplant. Suitable candidates for this trial are those aged 18 or older who are on the lung transplant list and do not have allergies to milk or soy protein. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance transplant outcomes.

Will I have to stop taking my current medications?

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 this nutritional supplement is safe for lung transplant patients?

Research has shown that nutritional support, such as Ensure Enlive, is generally safe for lung transplant patients. Some individuals might experience issues with food processing, though this is uncommon.

Studies indicate that good nutrition can enhance recovery after surgery, aiding healing and reducing the risk of complications like bed sores. While long-term issues may still occur after a lung transplant, nutritional supplements are commonly used to potentially improve overall health.

Ensure Enlive, a protein-rich shake, is often used to address malnutrition in lung transplant patients. Its widespread use has established its safety, as it has been tested in many individuals, making it a safe option for most. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for lung transplant complications, which typically involves medications and medical procedures, Ensure Enlive is unique because it focuses on nutritional supplementation. This treatment is exciting because it provides a non-invasive option that supports patients' overall health through enhanced nutrition, potentially improving recovery and outcomes during the pre-transplant period. Ensure Enlive is packed with essential nutrients designed to promote muscle health, which could help patients maintain their strength and better withstand the stress of a transplant. Researchers are eager to see if this nutritional approach can complement existing treatments and offer additional benefits to lung transplant patients.

What evidence suggests that Ensure Enlive might be an effective treatment for lung transplant complications?

Research has shown that nutritional supplements can greatly benefit lung transplant patients. Studies have found a link between good nutrition and better recovery with fewer complications after a lung transplant. In this trial, participants will receive Ensure Enlive, a protein-rich shake designed to enhance muscle mass and overall nutrition. Previous patients demonstrated improved nutrition, which is crucial for recovery and risk reduction. This makes Ensure Enlive a promising option for those awaiting a lung transplant to combat malnutrition, a known risk factor for poor outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Errol Bush, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are on the waiting list for a single or double lung transplant and have agreed to participate. It's not suitable for individuals with Galactosemia, milk protein allergy, or soy protein allergy.

Inclusion Criteria

I am 18 or older and listed for a lung transplant.

Subject provides written informed consent to participate in this study

Exclusion Criteria

You have had an allergic reaction to soy protein in the past.

You have had an allergic reaction to milk protein in the past.

I have a history of Galactosemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional shakes (Ensure Enlive) twice per day orally while awaiting lung transplant

Pre-transplant period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ensure Enlive

Trial Overview The study is testing if Ensure Enlive, a protein-rich nutritional shake, can help maintain muscle mass and improve nutrition in patients awaiting lung transplants when measured by ultrasound and Nutritional Risk Index.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant

Ensure Enlive is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ensure Enlive for:

• Nutritional support for patients with malnutrition, including those with liver disease

Approved in European Union as Ensure Enlive for:

• Nutritional support for patients with malnutrition, including those with liver disease

Approved in Canada as Ensure Enlive for:

• Nutritional support for patients with malnutrition, including those with liver disease

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Abbott Nutrition

Industry Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

The implementation of an evidence-based nutrition enhancement protocol (EP) significantly improved the delivery of enteral nutrition (EN) in critically ill trauma and surgical patients, increasing the average percentage of nutrition delivered from 75.3% to 85.5%.

The percentage of patients receiving more than 80% of their nutrition goals also rose from 52.7% to 65.2%, demonstrating that the EP aligns with national guidelines and effectively supports better nutritional outcomes in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving enteral nutrition delivery in the critically ill trauma and surgical population. McCartt, J., Loszko, A., Backes, K., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-5-2022-facbb

Nutritional Supplementation for Lung Transplant Complications This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9372663/

Evaluation of nutritional status in lung transplant recipients ... We retrospectively analyzed the nutritional status of lung transplantation recipients and explore its correlation with the short-term prognosis.

3. researchgate.net researchgate.net/publication/394940314_Nutritional_Support_Strategies_in_Lung_Transplant_Recipients_A_Narrative_Review

Nutritional Support Strategies in Lung Transplant Recipients Nutritional interventions after surgery support immune function, promote healing, and prevent complications. Long-term nutrition support focuses on preventing ...

4. mdpi.com mdpi.com/2072-6643/10/6/790

Nutritional Requirements of Lung Transplant Recipients As time from transplantation increases, complications such as obesity, osteoporosis, cancer, diabetes, and kidney disease, may develop and require adjustments ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352939319300478

Optimization of nutritional management of patients awaiting ... The aims of this study were to provide an insight into the pre- and post-lung transplant nutritional status and nutritional management of these patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6024852/

Nutritional Requirements of Lung Transplant Recipients As time from transplantation increases, complications such as obesity, osteoporosis, cancer, diabetes, and kidney disease, may develop and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1015958425022614

Enhanced recovery after surgery (ERAS) in lung ... Malnutrition is an important and potentially changeable risk factor for adverse outcomes after major surgery. Routinely taking oral nutritional ...

8. uab.edu uab.edu/medicine/transplant/images/education/Nutrition_in_Organ_Transplant_.pdf

Nutrition in Organ Transplant Numerous studies have shown that nutrition intervention leads to significant improvements in patient outcomes. ▫ Pressure ulcer incidence ...

9. ccts.amegroups.org ccts.amegroups.org/article/view/51876/html

Chronic and long-term complications after lung transplant Long-term medical complications after LT are diverse and encompass predominantly events related to infections, chronic rejection, malignancy, or sequelae of ...