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Protein Supplement

Nutritional Supplementation for Lung Transplant Complications

N/A

Waitlist Available

Led By Errol Bush, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects 18 years or older who are listed for single or double lung transplant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-transplant

Awards & highlights

Study Summary

This trial is testing whether a nutritional supplement can help treat malnutrition in lung transplant patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort due to intolerance to ingredients like lactose or soy found in Ensure Enlive. However, specific side effects aren't listed as it's generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps

Secondary outcome measures

Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,755 Total Patients Enrolled

Abbott NutritionIndustry Sponsor

168 Previous Clinical Trials

33,479 Total Patients Enrolled

Errol Bush, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Ensure Enlive (Protein Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04522388 — N/A

Lung Transplant Complications Research Study Groups: Treatment

Lung Transplant Complications Clinical Trial 2023: Ensure Enlive Highlights & Side Effects. Trial Name: NCT04522388 — N/A

Ensure Enlive (Protein Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04522388 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities open for this clinical trial presently?

"According to the clinicaltrials.gov listing, this trial is not presently enlisting participants. Initially posted on September 1st 2022 and last updated on September 14th of that same year, no volunteers are being sought at the present time; however, 10 other trials have open recruitment positions available right now."

Answered by AI

Recent research and studies

The Annals of Thoracic SurgeryJournal

Sarcopenia of the Psoas Muscles Is Associated with Poor Outcomes Following Lung Transplantation

Hsu, Joshua, Aravind Krishnan, Cheng T. Lin, Pali D. Shah, Stephen R. Broderick, Robert S.D. Higgins, Christian A. Merlo, and Errol L. Bush. 2019. “Sarcopenia of the Psoas Muscles Is Associated with Poor Outcomes Following Lung Transplantation”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2018.10.006.

The Journal of Heart and Lung TransplantationJournal

Impact of Nutritional State on Lung Transplant Outcomes

Chamogeorgakis, Themistokles, David P. Mason, Sudish C. Murthy, Lucy Thuita, Daniel P. Raymond, Gösta B. Pettersson, and Eugene H. Blackstone. 2013. “Impact of Nutritional State on Lung Transplant Outcomes”. The Journal of Heart and Lung Transplantation. Elsevier BV. doi:10.1016/j.healun.2013.04.005.

clinicaltrials.govStudy

Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

2023. "Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04522388.