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A Study to Explore the Role of Gut Flora in COVID-19 Infection

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04359836
Enrollment
250
Registered
2020-04-24
Start date
2020-04-16
Completion date
2027-07-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronaviridae Infections, Coronavirus, Coronavirus 19, Coronavirus-19, Corona Virus Infection, COVID, COVID 19, COVID-19, Gastrointestinal Microbiome, Gut Microbiome

Keywords

Microbiome, Coronavirus, Corona Virus, 19, COVID, COVID-19

Brief summary

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

Detailed description

In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Interventions

There is no intervention in this study

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. Male or female of 18 years of age or older 3. Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening

Exclusion criteria

1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Treatment with total parenteral nutrition

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome SequencingOne yearRelative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Secondary

MeasureTime frameDescription
Validation of Sequencing MethodsOne yearTo validate the methods used to sequence samples

Countries

United States

Contacts

Primary ContactSabine Hazan, MD
drsabinehazan@progenabiome.com805-339-0549
Backup ContactJordan Daniels, MS
jordan@progenabiome.com217-494-6692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026