Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing.
Andreas Papoutsis, Thomas Borody, Siba Dolai...
https://pubmed.ncbi.nlm.nih.gov/33516247Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID04359836
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
Led by ProgenaBiome · Updated on 2025-06-05
250
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring whether the virus that causes COVID-19, called SARS-CoV-2, is present in the stool of infected patients. The study aims to understand the role of gut flora during and after COVID-19 infection by examining stool samples for viral shedding. This non-interventional pilot study is led by ProgenaBiome and focuses on the gastrointestinal microbiome in people diagnosed with COVID-19. Participants will provide stool samples that will be analyzed to sequence the microbiome. Samples will be collected during treatment for COVID-19 and again after treatment to determine if and when the virus is shed in the stool. The study involves observing the general population's microbiome through these samples without any intervention or treatment imposed. During the study, participants will have their stool microbiome sequenced to analyze the relative abundance of microbes and correlate it with the disease over the course of one year. Researchers will validate sequencing methods and monitor the gut microbiome changes. The study includes follow-up assessments and does not involve any active treatment, focusing instead on data collection and analysis over the study period.
CONDITIONS
Brief Title
A Study to Explore the Role of Gut Flora in COVID-19 Infection
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Signed informed consent showing understanding of study procedures and purpose
- Male or female aged 18 years or older
- Diagnosed with COVID-19 infection by RT-PCR within 1 week of screening
You will not qualify if you...
- Refusal to sign informed consent form
- History of bariatric surgery, total colectomy with ileorectal anastomosis, or proctocolectomy
- Presence of postoperative stoma, ostomy, or ileoanal pouch
- Currently treated with total parenteral nutrition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 1 year
Participants provide stool samples during and following their COVID-19 treatment to determine viral shedding and analyze gut flora.
Trial Site Locations
Total: 1 location
1
ProgenaBiome
Ventura, California, United States, 93003
Actively Recruiting
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Research Team
S
Sabine Hazan, MD
J
Jordan Daniels, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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