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

• ClinicalTrials.gov Identifier: NCT04399252
• Recruitment Status: Completed
• First Posted: May 22, 2020
• Last Update Posted: March 15, 2022
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: May 19, 2020
• First Posted Date: May 22, 2020
• Last Update Posted Date: March 15, 2022
• Actual Study Start Date: June 24, 2020
• Actual Primary Completion Date: July 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2021)

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

• Original Primary Outcome Measures (submitted: May 21, 2020): Change in Shannon Diversity [ Time Frame: Baseline, Day 7, and Day 28 ]

Current Secondary Outcome Measures (submitted: March 29, 2021)

• 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
• Complications of COVID-19 [ Time Frame: 60 days ]
  Complications of COVID-19 (e.g., need for hospitalization, intubation, mortality) during the study period
• 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)
• Duration of symptoms of COVID-19 [ Time Frame: 60 days ]
  Duration of symptoms (days) of COVID-19 during the study period

• Original Secondary Outcome Measures (submitted: May 21, 2020): Change in Shannon Diversity in patients that develop COVID-19 [ Time Frame: Baseline, Day 7, and Day 28 ]

Current Other Pre-specified Outcome Measures (submitted: March 29, 2021)

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

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
• Official Title: A Randomized Trial of the Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Microbiome

Intervention

• 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

Study Arms

• Experimental: LGG Arm
  Participants in this arm will be given LGG for 28 days.
  Intervention: Dietary Supplement: Lactobacillus rhamnosus GG
• Placebo Comparator: Placebo
  Participants in this arm will be given a placebo for 28 days.
  Intervention: Dietary Supplement: Lactobacillus rhamnosus GG Placebo

• Publications *: Tang H, Bohannon L, Lew M, Jensen D, Jung SH, Zhao A, Sung AD, Wischmeyer PE. Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol. BMJ Open. 2021 May 5;11(5):e047069. doi: 10.1136/bmjopen-2020-047069.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2021): 182
• Original Estimated Enrollment (submitted: May 21, 2020): 1000
• Actual Study Completion Date: July 8, 2021
• Actual Primary Completion Date: July 8, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04399252
• Other Study ID Numbers: Pro00105674
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anthony Sung, MD; Duke University
• Principal Investigator: Paul Wischmeyer, MD; Duke University

• PRS Account: Duke University
• Verification Date: February 2022