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

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.

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.

Is the nutritional supplementation used in lung transplant patients generally safe?

The research indicates that nutritional support for lung transplant patients is generally safe, but some patients may experience metabolic complications like azotemia (high levels of nitrogen waste in the blood), hyperglycemia (high blood sugar), and hypomagnesemia (low magnesium levels). ^{1 2 3 4 5}

How is the treatment Ensure Enlive unique for lung transplant complications?

Ensure Enlive is unique because it is a nutritional supplement specifically designed to support patients' nutritional needs, which is crucial for lung transplant recipients who often face gastrointestinal complications and require careful nutrition management to improve recovery and manage comorbid conditions. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Ensure Enlive for lung transplant complications?

The research highlights the importance of nutrition therapy in managing lung transplant patients, especially those with malnutrition, which is common in conditions like cystic fibrosis. While Ensure Enlive is not specifically mentioned, maintaining adequate nutrition is crucial for recovery and managing complications after lung transplantation. ^{1 2 5 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. United States pubmed.ncbi.nlm.nih.gov

Nutrition support for lung transplant patients. [2017]

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

Current nutrition practices in adult lung transplantation. [2017]

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

Influence of nutritional status in lung transplant recipients. [2006]

4. Brazil pubmed.ncbi.nlm.nih.gov

Nutritional profile of lung transplant candidates. [2019]

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

Impact of nutritional state on lung transplant outcomes. [2013]

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

Effect of standardized enteral nutrition on AECOPD patients with respiratory failure. [2021]

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

Improving enteral nutrition delivery in the critically ill trauma and surgical population. [2022]

8. England pubmed.ncbi.nlm.nih.gov

ESPEN Guidelines on Enteral Nutrition: Cardiology and pulmonology. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nutritional support in patients with chronic obstructive pulmonary disease during hospitalization for an acute exacerbation; a randomized controlled feasibility trial. [2004]