Trials / Completed
CompletedNCT04399252
Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
A Randomized Trial of the Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 182 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus rhamnosus GG | Participants will take 2 capsules per day of either LGG or placebo. |
| DIETARY_SUPPLEMENT | Lactobacillus rhamnosus GG Placebo | Participants will take 2 capsules per day of LGG placebo |
Timeline
- Start date
- 2020-06-24
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
- First posted
- 2020-05-22
- Last updated
- 2024-04-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04399252. Inclusion in this directory is not an endorsement.