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

NCT04359836 | Recruiting

• 1 other identifier: PRG-041
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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; Coronavirus; Coronaviridae Infections; Coronavirus 19; Coronavirus-19; COVID 19

Keywords

Microbiome; Coronavirus; Corona Virus; 19; COVID; COVID-19

Outcome Measures

Primary Outcomes (1)

• Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

  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.

  One year

Secondary Outcomes (1)

• Validation of Sequencing Methods

  One year

Study Arms (1)

General Population

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

Other: There is no intervention in this study

Interventions

There is no intervention in this study OTHER

There is no intervention in this study

General Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 and older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

RECRUITING

Related Publications (1)

• Papoutsis A, Borody T, Dolai S, Daniels J, Steinberg S, Barrows B, Hazan S. Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing. Gut Pathog. 2021 Jan 30;13(1):7. doi: 10.1186/s13099-021-00398-5.

  PMID: 33516247 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Coronaviridae Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Hazan, MD

CONTACT

805-339-0549; drsabinehazan@progenabiome.com

Jordan Daniels, MS

CONTACT

217-494-6692; jordan@progenabiome.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: April 16, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)