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Completed

NCT Number: NCT04399252

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

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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Key information

Conditions

Microbiome COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

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

Lactobacillus rhamnosus GG Placebo

Dietary Supplement

Participants will take 2 capsules per day of LGG placebo

Primary outcomes

  1. Incidence of one or more symptoms of COVID-19 during the study period

    Time frame: 60 days

    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

Secondary outcomes

  1. Incidence of laboratory-confirmed COVID-19 during the study period

    Time frame: 60 days

    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

  2. Complications of COVID-19

    Time frame: 60 days

    Complications of COVID-19 (e.g., need for hospitalization, intubation, mortality) during the study period

  3. Types of symptoms of COVID-19

    Time frame: 60 days

    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)

  4. Duration of symptoms of COVID-19

    Time frame: 60 days

    Duration of symptoms (days) of COVID-19 during the study period

Other outcomes

  1. Change in Shannon Diversity in patients that develop COVID-19

    Time frame: Baseline, Day 7, Day 28

    Impact of COVID-19 on and of the microbiome, as determined by Shannon Diversity of stool and nasal swab samples, during the study period

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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