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

Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399252
• Other study ID #: Pro00105674
• Status: Completed
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: July 8, 2021

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Microbiome

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG
Participants will take 2 capsules per day of either LGG or placebo.
• Lactobacillus rhamnosus GG Placebo
Participants will take 2 capsules per day of LGG placebo

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	Complications of COVID-19	Complications of COVID-19 (e.g., need for hospitalization, intubation, mortality) during the study period	60 days
Secondary	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
Secondary	Duration of symptoms of COVID-19	Duration of symptoms (days) of COVID-19 during the study period	60 days

External Links

•   Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial