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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399252
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Microbiome Dietary Supplement: Lactobacillus rhamnosus GG Dietary Supplement: Lactobacillus rhamnosus GG Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized Trial of the Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
Actual Study Start Date : June 24, 2020
Actual Primary Completion Date : July 8, 2021
Actual Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LGG Arm
Participants in this arm will be given LGG for 28 days.
 Dietary Supplement: Lactobacillus rhamnosus GG
Participants will take 2 capsules per day of either LGG or placebo.
Placebo Comparator: Placebo
Participants in this arm will be given a placebo for 28 days.
 Dietary Supplement: Lactobacillus rhamnosus GG Placebo
Participants will take 2 capsules per day of LGG placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399252


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Anthony Sung, MD Duke University
Principal Investigator: Paul Wischmeyer, MD Duke University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04399252    
Other Study ID Numbers: Pro00105674
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
COVID-19
Lactobacillus rhmanosus GG
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases