Recruiting

Gut Flora

Sponsor:

ProgenaBiome

Code:

NCT04359836

Conditions

Gut Microbiome

Gastrointestinal Microbiome

COVID

COVID-19

Corona Virus Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

There is no intervention in this study

Study Details

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.

Conditions

Gut Microbiome

Gastrointestinal Microbiome

COVID

COVID-19

Corona Virus Infection

Study ID

NCT04359836

Start date

Apr 16, 2020

Status verified date

Jun, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

General Population

The general population will have their microbiome sequenced from stool samples provided.

Interventions

There is no intervention in this study

There is no intervention in this study

Primary outcome measure

  • Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Sabine Hazan, MD

805-339-0549drsabinehazan@progenabiome.com

Jordan Daniels, MS

217-494-6692jordan@progenabiome.com

Locations

ProgenaBiome

Recruiting

Ventura, California, United States, 93003

Contacts

Sabine Hazan, MD

805-339-0549drsabinehazan@progenabiome.com

Jordan Daniels, MS

805-339-0549jordan@progenabiome.com

Principal Investigator:

Sabine Hazan, MD

More Information

Sponsor

ProgenaBiome

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Keywords

  • Microbiome
  • Coronavirus
  • Corona Virus
  • 19
  • COVID
  • COVID-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ProgenaBiome on 2025-06-05.