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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 body) in exposed household contacts of COVID-19. This is a randomized, double-blind, placebo-controlled study, meaning subjects will be randomly assigned to receive LGG or a placebo (an inactive substance given in the same form as the active substance) and will not know which product they are receiving. Subjects will participate in the study for around 60 days. All subjects must refrain from taking any other probiotics while on study. All subjects must have access to e-mail and the internet to complete study questionnaires. Participation in this study entails taking LGG/placebo for 28 days, responding to questionnaires, and providing stool and nasal swab samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGG Arm | Experimental | Participants in this arm will be given LGG for 28 days. |
|
| Placebo | Placebo Comparator | Participants in this arm will be given a placebo for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus GG | Dietary Supplement | Participants will take 2 capsules per day of either LGG or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of one or more symptoms of COVID-19 during the study period | Incidence of one or more symptoms of COVID-19 (fever, chills, headache, muscle aches, runny nose, sore throat, cough, shortness of breath, nausea or vomiting, diarrhea, stomach upset or pain, excessive bloating or gas, constipation, loss of sense of smell, loss of sense of taste, rash, painful toes, or other symptoms related to COVID-19 diagnosis) during the study period | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of laboratory-confirmed COVID-19 during the study period | Incidence of laboratory-confirmed COVID-19 (all based on medically-dictated, clinical testing and electronic medical record review) or research laboratory-confirmed COVID-19 (all, based on research testing of nasal swab and stool samples) during the study period | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shannon Diversity in patients that develop COVID-19 | Impact of COVID-19 on and of the microbiome, as determined by Shannon Diversity of stool and nasal swab samples, during the study period | Baseline, Day 7, Day 28 |
Inclusion Criteria:
Exclusion Criteria:
Symptoms of COVID-19 at enrollment, including:
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:
Increased infection risk due to endovascular due to:
Increased infection risk due to mucosal gastrointestinal due to:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Sung, MD | Duke University | Principal Investigator |
| Paul Wischmeyer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38103462 | Derived | Wischmeyer PE, Tang H, Ren Y, Bohannon L, Jiang D, Bergens M, Ramirez ZE, Andermann TM, Messina JA, Sung JA, Jensen D, Jung SH, Artica A, Britt A, Bush A, Johnson E, Lew MV, Winthrop H, Pamanes C, Racioppi A, Zhao AT, Wan Z, Surana NK, Sung AD. Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial. Clin Nutr. 2024 Jan;43(1):259-267. doi: 10.1016/j.clnu.2023.11.043. Epub 2023 Dec 11. | |
| 33952552 |
| Label | URL |
|---|---|
| Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Lactobacillus rhamnosus GG Placebo | Dietary Supplement | Participants will take 2 capsules per day of LGG placebo |
|
| Complications of COVID-19 |
Complications of COVID-19 (e.g., need for hospitalization, intubation, mortality) during the study period |
| 60 days |
| Types of symptoms of COVID-19 | Types of symptoms of COVID-19 during the study period (e.g., fever, chills, headache, muscle aches, runny nose, sore throat, cough, shortness of breath, nausea or vomiting, diarrhea, stomach upset or pain, excessive bloating or gas, constipation, loss of sense of smell, loss of sense of taste, rash, painful toes, or other symptoms related to COVID-19 diagnosis) | 60 days |
| Duration of symptoms of COVID-19 | Duration of symptoms (days) of COVID-19 during the study period | 60 days |
| Derived |
| Tang H, Bohannon L, Lew M, Jensen D, Jung SH, Zhao A, Sung AD, Wischmeyer PE. Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol. BMJ Open. 2021 May 5;11(5):e047069. doi: 10.1136/bmjopen-2020-047069. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |