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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

Tracking Information
First Submitted Date  ICMJE May 19, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date March 15, 2022
Actual Study Start Date  ICMJE June 24, 2020
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: May 21, 2020)
Change in Shannon Diversity [ Time Frame: Baseline, Day 7, and Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Microbiome
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
182
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2020)
1000
Actual Study Completion Date  ICMJE July 8, 2021
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04399252
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony Sung, MD Duke University
Principal Investigator: Paul Wischmeyer, MD Duke University
PRS Account Duke University
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP