COVID-19 Probiotic Clinical Trials

 

 

 

Probiotics To Eliminate COVID-19 Transmission (PROTECT) Clinical Trials:
These clinical trials will study the effects of probiotics in people who are at higher risk of COVID-19 infection. These include:

 

  • PROTECT-EHC:
    Exposed household contacts (EHC) are people who live with someone with COVID-19. This puts them at higher risk of getting the virus. Thanks to a grant from the Duke Microbiome Center and philanthropic support, this study is already open and enrolling patients. However, we are seeking additional funding to translate study materials into other languages and hire bilingual research coordinators to enroll patients who do not speak English. To learn more, please visit sites.duke.edu/protectehc.
    If you or someone you know lives with a person who has been diagnosed with COVID-19 in the past 48 hours, please email our study team at PROTECT-EHC@duke.edu.

 

  • PROTECT-Surgery:
    Patients having surgery have a higher risk of getting COVID-19. Their infection may also be worse. We have recently submitted a grant application to the Patient-Centered Outcomes Research Institute (PCORI) for a large, multi-center study of the use of probiotics to prevent COVID-19 infection in patients having surgery.

 

  • PROTECT-Healthcare:
    Healthcare workers are at a much higher risk of being exposed to and contracting COVID-19. We are developing a study to protect people who work in places where healthcare is delivered.

 

  • PROTECT-Military:
    After the COVID-19 outbreak on the USS Theodore Roosevelt, it became apparent that military personnel are at risk of COVID-19 due to close-quarters. An outbreak may threaten the deployment of soldiers and our nation’s ability to respond to external threats, and we are interested in developing on-demand interventions to prevent future outbreaks.

 

  • PROTECT-Facilities:
    Residents of nursing facilities, group homes, and homeless shelters are amongst the hardest-hit by COVID-19 due to higher baseline risk factors and close-quarter residency. Although studies in these populations would be logistically challenging, they are urgently needed.

 

 

What your contributions will support

 

These studies done by a research team under the leadership of:


-   Anthony Sung, MD; Assistant Professor of Medicine, Duke University School of Medicine; Associate Director, Duke Microbiome Center; Senior Fellow, Duke            Center for the Study of Aging and Human Development; Member, Food and Drug Administration Oncologic Drugs Advisory Committee (FDA ODAC)

 

-   Paul E. Wischmeyer MD, EDIC, FASPEN, FCCM; Professor with Tenure of Anesthesiology and Surgery, Duke University School of Medicine; Director of                  Duke Hospital TPN/Nutrition Service; Associate Vice-Chair of Clinical Research in Anesthesiology.

 

Summary of Dr. Sung’s Research:                                                                                                                                             
sung.jpg

Dr. Sung oversees a large research program that includes lab-based studies that have successfully moved into phase 1 and phase 2 randomized clinical trials inhumans. This includes work on the impact of the microbiome on outcomes from infectious diseases.

  • National Institute of Allergy and Infectious Diseases (NIAID),
  • National Heart, Lung, and Blood Institute (NHLBI),
  • National Cancer Institute (NCI), National Center for Advancing Translational Science (NCATS), and
  • National Institute of Aging (NIA)

He also has research funded by non-profit foundations, including the

  • American Society of Hematology
  • Leukemia and Lymphoma Society
  • Damon Runyon Cancer Research Foundation

While his background is in stem cell transplantation, Dr. Sung is also an expert in the microbiome. Because of the urgency of COVID-19, and his personal experience with his 18 month-old daughter spending her first two Christmases in the intensive care unit with respiratory viruses, Dr. Sung has shifted the focus of his research to include studies of COVID-19. 

 

 

Summary of Dr. Wischmeyer’s Research:                                                                                                                                         paul.jpg

Dr. Wischmeyer also oversees a large research program that includes a range of lab-based probiotic and other nutrition studies that have successfully moved into phase 1, 2,  and 3 randomized clinical trials in humans. This includes work on the impact of the microbiome and probiotics on outcomes from infectious diseases.

Dr. Wischmeyer has received NIH and Government funding from:

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of General Medical Sciences (NIGMS)
  • National Institute of Aging (NIA)
  • National Institute of Diabetes and Digestive and Kidney Diseases ()NIDDK
  • Department of Defense and Canadian Institutes of Health Research (CIHR)

He also has research funded by non-profit foundations to both himself and the young physician-researchers he mentors, including the

  • American Society of Parenteral and Enteral Nutrition (ASPEN)
  • Foundation for Anesthesiology Education and Research (FAER)
  • International Anesthesia Research Foundation (IARS)
  • American Heart Association (AHA)

While his background is in critical care, perioperative medicine, and nutrition- Dr. Wischmeyer is also an expert in the microbiome and probiotic research. Dr. Wischmeyer’s his passion for research to improve patient’s suffering from illness comes from his experience as a lifelong patient since age 15, when he was diagnosed with Inflammatory Bowel Disease (Ulcerative Colitis) and was hospitalized for nearly a year. Since then he has had 23 major surgeries with many ICU stays, leaving him with about half of his intestine remaining and he has had an ostomy for much of his life. As a vulnerable patient himself, Dr. Wischmeyer realizes the urgency of COVID-19 for us all, and he has shifted the focus of his research to include studies of COVID-19. 

Dr. Sung and Dr. Wischmeyer have also taken the unusual step of asking for your generous financial support so that clinical trials can be started as soon as possible. This is in contrast to traditional grant mechanisms that support their other research but may take up to a year to be approved.

Dr. Sung, Dr. Wischmeyer and other senior researchers are donating their time to these projects. Your generous donation will not be used to support their salaries.  Dr. Wischmeyer and Dr. Sung have also secured a commitment from iHealth to donate probiotics for these studies. Hence, no money will go toward pharmaceutical partners. Rather, your donations will support clinical research staff who will engage and enroll patients, dispense probiotics and follow-up with participants, supplies to ship probiotics to patients and receive and process samples, and other essential research operations. 

 

To help support these COVID-19 studies, please click here.

If you are interested in learning more about Dr. Sung’s other research, please click here.

If you are interested in learning more about Dr. Wischmeyer’s other research, please click here.