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NCT04399252 · ClinicalTrials.gov registry record · NA
Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
NCT04399252: Completed NA study, sponsored by Duke University.
NCT04399252 is a NA study that has completed, run by Duke University. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04399252, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DIETARY_SUPPLEMENT Lactobacillus rhamnosus GG
- DIETARY_SUPPLEMENT Lactobacillus rhamnosus GG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2021-07-08 |
| Phase | NA |
What the finished NCT04399252 record still lists
NCT04399252 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Lactobacillus rhamnosus GG is the first listed.
NCT04399252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04399252 about?
NCT04399252 is a clinical study titled "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...
What is the current status of trial NCT04399252?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2020-06-24. Estimated completion is 2021-07-08.
What interventions are being tested in trial NCT04399252?
The interventions under investigation include: Lactobacillus rhamnosus GG (DIETARY_SUPPLEMENT), Lactobacillus rhamnosus GG Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04399252?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04399252's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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