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

What is the Purpose of this Study?

We are doing this study to learn more about how the probiotic, LGG, affects the microbiome (the microorganisms that live in and on the human body) in people that have household contact with someone that has COVID-19.

LGG is a type of probiotic, which is made of live bacteria that can improve gut health and potentially improve the immune system and prevent infections.

To learn more about this study, please visit us at: https://sites.duke.edu/protectehc/about-our-study/

Estamos haciendo este estudio para aprender más sobre cómo el probiótico, LGG, afecta al microbioma (los microorganismos que viven sobre y dentro del cuerpo humano) en aquellos que viven con personas que tienen COVID-19.

LGG es un tipo de probiótico, que está hecho de bacterias vivas que pueden mejorar su salud intestinal y potencialmente mejorar su sistema inmune y prevenir infecciones.

Para más información sobre este estudio, por favor visite la página: https://sites.duke.edu/protectehc/about-our-study/

What is the Condition Being Studied?

COVID-19

Who Can Participate in the Study?

-Children aged 1+ and adults
-Live with someone diagnosed with COVID-19
-Access to e-mail and internet
-Not currently showing signs of COVID-19

-Niños a partir del año de edad y adultos
-Personas que vivan con alguien que haya sido diagnosticado con COVID-19
-Personas que tengan acceso a una cuenta de correo electrónico y a internet
-Personas que No tengan síntomas de COVID-19

Age Group
Adults, Children

What is Involved?

If you choose to join this study you will:
-Be randomized (like flipping a coin) to group 1 or group 2
--Group 1 will take the probiotic LGG (Lactobacillus rhamnosus GG) for 28 days
--Group 2 will take a placebo (harmless pill) for 28 days
-Send in 3 stool samples over 28 days
-Send in 3 nasal samples over 28 days
-Complete online questionnaires over 60 days

Si usted decide participar en este estudio, usted:
-Será aleatoriamente asignado (como lanzar una moneda al aire) al grupo 1 o al grupo 2
--Grupo 1 tomará el probiótico LGG (Lactobacillus rhamnosus GG) por 28 días
--Grupo 2 tomará placebo (pastilla segura de tomar, sin efecto terapéutico) por 28 días
-Nos enviará 3 muestras de heces (popo) en el trascurso de 28 días
-Nos enviará 3 muestras de exudado nasal en el trascurso de 28 días
-Completará cuestionarios electrónicos en el trascurso de 60 días

Study Details

Full Title
A Randomized Trial of the Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00105674
NCT: NCT04399252
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698