Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: Duke University School of Medicine
Location: This is a nationwide study conducted online (no study visits)
Lead Researchers: Dr. Anthony Sung and Dr. Paul Wischmeyer
IRB Committee: This study has been reviewed and approved by the Duke University Medical Center Institutional Review Board

Background

 

Probiotics are live bacteria, usually in capsules, that are beneficial to the gut (intestinal microbiome). Probiotics have been proven to help the immune system and reduce occurrence and severity of  infections like pneumonia. The human body, including the gut, has microorganisms that play a crucial role in human health and disease. Disruptions to the normal balance of important microorganisms in the body may increase risk of some people becoming infected with COVID-19. 

This nationwide research study seeks to determine if taking a probiotic for 28 days can reduce the chance of becoming infected with COVID-19 and if it can, reduce symptoms, complications, and severity of COVID-19 if infection occurs. Researchers are interested to learn how probiotics and COVID-19 itself may change the normal bacteria in the gut to increase risk of severe infection. Further, this study may help in understanding which people have a greater risk of COVID-19 based on their gut bacterial make-up.

This study is seeking people exposed to people in their homes who have been diagnosed with COVID-19. Exposed household contacts (EHC) are those who live with someone with COVID-19 and therefore have an increased risk of contracting the virus. Interested participants must be willing to follow the study requirements. Compensation for eligible participants is available.

Why Participate? 

 

• Participants may have the opportunity to reduce the risk of COVID-19 infection and severity due to exposure from home and family contacts who have COVID-19 with this intervention.
• Participants may help develop a simple, inexpensive therapy for COVID-19 that may help reduce COVID-19 infection and symptoms/severity.
• Participants may contribute valuable information that may benefit many others in the future.
• Participants will be compensated up to $40 for participating in this study and completing all study endpoints.
• Participants will be helping to advance medical and COVID-19 research.
• Participants will be able to join this study without leaving home and without the need for in-person study visits since this study is conducted entirely online and all study materials are mailed to participants.

Your Rights

 

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

 

• Those who are living with someone diagnosed with COVID-19. It must be less than 3 days since the infected person has been diagnosed with COVID-19.
  • Please note that interested participants who are not of legal age must have parental or legal guardian consent to join this study.
• Participants must have easy access to the internet and their email.
• Participants must NOT be experiencing COVID-19 symptoms like fever, lung (i.e. breathing problems) and stomach symptoms, loss of smell and taste.
• Participants must be able to complete online assessments and surveys; the study team will send 6 surveys over the 60 day study course (less than once per week on average). 
  • This study involves optional nasal swabs and stool sample collections for the researchers to better understand the effect of probiotics and COVID-19; the study team can elaborate further on this.
  • The study team will provide the participants with the study product and instructions on how to take it. Participants are to reach out to the study team if they have not received their study package after 2 days or if they have any questions.

About the Research Centers:

 

Please note:

 

Due to the current situation with the COVID-19 pandemic, the study team would like to note the following:

• This is a nationwide study conducted online which means you can participate in the comfort of your own home. 
• There will be no in-person visits or clinic appointments in this study.
• In this study, there is no need to have close interactions with any person.