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

Primary Purpose

Microbiome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lactobacillus rhamnosus GG

Lactobacillus rhamnosus GG Placebo

About this trial

This is an interventional basic science trial for Microbiome focused on measuring COVID-19, Lactobacillus rhmanosus GG

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LGG Arm

Placebo

Arm Description

Participants in this arm will be given LGG for 28 days.

Participants in this arm will be given a placebo for 28 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Complications of COVID-19

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

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)

Duration of symptoms of COVID-19

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

Full Information

NCT ID

NCT04399252

First Posted

May 19, 2020

Last Updated

September 26, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT04399252

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 24, 2020 (Actual)

Primary Completion Date

July 8, 2021 (Actual)

Study Completion Date

July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microbiome

Keywords

COVID-19, Lactobacillus rhmanosus GG

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LGG Arm

Arm Type

Experimental

Arm Description

Participants in this arm will be given LGG for 28 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants in this arm will be given a placebo for 28 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus rhamnosus GG

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus rhamnosus GG Placebo

Intervention Description

Participants will take 2 capsules per day of LGG placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

60 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

60 days

Title

Complications of COVID-19

Description

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

Time Frame

60 days

Title

Types of symptoms of COVID-19

Description

Time Frame

60 days

Title

Duration of symptoms of COVID-19

Description

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

Time Frame

60 days

Other Pre-specified Outcome Measures:

Title

Change in Shannon Diversity in patients that develop COVID-19

Description

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

Time Frame

Baseline, Day 7, Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Sung, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul Wischmeyer, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33952552

Citation

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.

Results Reference

derived

Links:

URL

https://www.medrxiv.org/content/10.1101/2022.01.04.21268275v1

Description

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

Learn more about this trial

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

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