Status:
COMPLETED
Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
Lead Sponsor:
Duke University
Conditions:
Microbiome
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of the probiotic Lactobacillus rhamnosus GG (LGG) and the effect of COVID-19 on the microbiome (the microorganisms that live in and on the human bod...
Eligibility Criteria
Inclusion
- Age \>=1 year (as children \<1 year may not be able to take oral probiotics)
- Household contact of someone diagnosed with COVID-19
- Willingness to stop taking other probiotics or to not take any other probiotic while on LGG/placebo (taking a probiotic at the time of screening will not be considered a reason for exclusion. However, subjects will be asked to stop taking their probiotic if they enroll on the study).
- Access to e-mail/internet to complete electronic consent via REDCap
Exclusion
- Symptoms of COVID-19 at enrollment, including:
- Fever
- Respiratory symptoms
- GI symptoms
- Anosmia
- Ageusia -\>7 days since original patient associated with household contact was diagnosed with COVID-19
- Taking hydroxychloroquine or remdesivir for any reason (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
- Enrolled in a COVID-19 prophylaxis study (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
- Any medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to:
- Inability to swallow/aspiration risk and no other methods of delivery (e.g., no G/J tube)
- Increased infection risk due to immunosuppression due to:
- Chronic immunosuppressive medication
- Prior organ or hematopoietic stem cell transplant
- Known neutropenia (ANC \<500 cells/ul)
- HIV and CD4 \<200 cells/ul
- Increased infection risk due to endovascular due to:
- Rheumatic heart disease
- Congenital heart defect,
- Mechanical heart valves
- Endocarditis
- Endovascular grafts
- Permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators
- Increased infection risk due to mucosal gastrointestinal due to:
- Gastroesophageal or intestinal injury, including active bleeding
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04399252
Start Date
June 24 2020
End Date
July 8 2021
Last Update
April 17 2024
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710