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

NCT ID: NCT04359836

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-16

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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General Population

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

There is no intervention in this study

Intervention Type OTHER

There is no intervention in this study

Interventions

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There is no intervention in this study

There is no intervention in this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

ProgenaBiome

Locations

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ProgenaBiome

Ventura, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sabine Hazan, MD

Role: CONTACT

805-339-0549

Jordan Daniels, MS

Role: CONTACT

217-494-6692

Facility Contacts

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Sabine Hazan, MD

Role: primary

805-339-0549

Jordan Daniels, MS

Role: backup

805-339-0549

References

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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.

Reference Type DERIVED
PMID: 33516247 (View on PubMed)

Other Identifiers

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PRG-041

Identifier Type: -

Identifier Source: org_study_id

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