Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2021-07-08

Brief Summary

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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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Detailed Description

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Conditions

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Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LGG Arm

Participants in this arm will be given LGG for 28 days.

Group Type EXPERIMENTAL

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Participants will take 2 capsules per day of either LGG or placebo.

Placebo

Participants in this arm will be given a placebo for 28 days.

Group Type PLACEBO_COMPARATOR

Lactobacillus rhamnosus GG Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will take 2 capsules per day of LGG placebo

Interventions

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Lactobacillus rhamnosus GG

Participants will take 2 capsules per day of either LGG or placebo.

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG Placebo

Participants will take 2 capsules per day of LGG placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes