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NCT Number: NCT04359836

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

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.

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Key information

Conditions

Gut Microbiome COVID COVID 19 COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Coronavirus 19 Coronavirus Infections Coronavirus-19 Gastrointestinal Microbiome Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

There is no intervention in this study

Other

There is no intervention in this study

Primary outcomes

  1. Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

    Time frame: One year

    Relative 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 outcomes

  1. Validation of Sequencing Methods

    Time frame: One year

    To validate the methods used to sequence samples

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Daniels, MS

CONTACT

[email protected]

217-494-6692

Sabine Hazan, MD

CONTACT

[email protected]

805-339-0549

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2020
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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