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

NCT04399252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-04-17

No results posted yet for this study

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

  • Microbiome

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Anthony Sung, MD · Duke University

  • Paul Wischmeyer, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2021-07-08
Completion
2021-07-08

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399252 on ClinicalTrials.gov