MicrobiomeNCT04399252
Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
A study testing Lactobacillus rhamnosus GG in people with Microbiome, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiome
- What is being tested?
- Lactobacillus rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2020to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of the 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.
- Conditions
- Microbiome
- Being tested
- Lactobacillus rhamnosus GG, Lactobacillus rhamnosus GG Placebo
- Keywords
- COVID-19, Lactobacillus rhmanosus GG
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GGDietary supplement
Participants will take 2 capsules per day of either LGG or placebo.
Lactobacillus rhamnosus GG PlaceboDietary supplement
Participants will take 2 capsules per day of LGG placebo
| Study group | Role | What they receive |
|---|---|---|
| LGG Arm | Experimental | Participants in this arm will be given LGG for 28 days. Receives: Dietary Supplement: Lactobacillus rhamnosus GG |
| Placebo | Placebo comparator | Participants in this arm will be given a placebo for 28 days. Receives: Dietary Supplement: Lactobacillus rhamnosus GG Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Secondary outcomes (4)
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
Measured: 60 days
Complications of COVID-19
Complications of COVID-19 (e.g., need for hospitalization, intubation, mortality) during the study period
Measured: 60 days
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)
Measured: 60 days
Duration of symptoms of COVID-19
Duration of symptoms (days) of COVID-19 during the study period
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start24 Jun 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Sung, MD, Principal investigator, Duke UniversityPaul Wischmeyer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399252
- Sponsor's protocol ID
- Pro00105674
- Status last verified
- Apr 2024
- First submitted
- 19 May 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wischmeyer PE, Tang H, Ren Y, Bohannon L, Jiang D, Bergens M, Ramirez ZE, Andermann TM, Messina JA, Sung JA, Jensen D, Jung SH, Artica A, Britt A, Bush A, Johnson E, Lew MV, Winthrop H, Pamanes C, Racioppi A, Zhao AT, Wan Z, Surana NK, Sung AD. Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial. Clin Nutr. 2024 Jan;43(1):259-267. doi: 10.1016/j.clnu.2023.11.043. Epub 2023 Dec 11.
PubMed 38103462Tang 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.
PubMed 33952552
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
- ClinicalTrials.gov ID
- NCT04399252
- Acronym / sponsor ID
- Pro00105674
- Conditions
- Microbiome
- Keywords
- COVID-19, Lactobacillus rhmanosus GG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG Arm | Experimental | Dietary Supplement: Lactobacillus rhamnosus GGParticipants in this arm will be given LGG for 28 days. |
| Placebo | Placebo comparator | Dietary Supplement: Lactobacillus rhamnosus GG PlaceboParticipants in this arm will be given a placebo for 28 days. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- Symptoms of COVID-19 at enrollment, including:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus GGParticipants will take 2 capsules per day of either LGG or placebo. | Dietary supplement | LGG Arm |
| Lactobacillus rhamnosus GG PlaceboParticipants will take 2 capsules per day of LGG placebo | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Incidence of laboratory-confirmed COVID-19 during the study period
Time frame: 60 days
Complications of COVID-19
Time frame: 60 days
Types of symptoms of COVID-19
Time frame: 60 days
Duration of symptoms of COVID-19
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 38103462Wischmeyer PE, Tang H, Ren Y, Bohannon L, Jiang D, Bergens M, Ramirez ZE, Andermann TM, Messina JA, Sung JA, Jensen D, Jung SH, Artica A, Britt A, Bush A, Johnson E, Lew MV, Winthrop H, Pamanes C, Racioppi A, Zhao AT, Wan Z, Surana NK, Sung AD. Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial. Clin Nutr. 2024 Jan;43(1):259-267. doi: 10.1016/j.clnu.2023.11.043. Epub 2023 Dec 11.
- Derived from this study: PubMed 33952552Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Sung, MD principal investigator
Duke University
Paul Wischmeyer, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus GG in people with Microbiome, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of one or more symptoms of COVID-19 during the study period (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399252, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.