ClinicalTrials.gg
SuspendedNCT04359836Updated Sep 21, 2026

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

An observational study in Gut Microbiome, Gastrointestinal Microbiome and COVID, sponsored by ProgenaBiome. Suspended at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by ProgenaBiome · Observational

Why this study was suspended
Administrative
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
250
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 250 is close to the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults 18 and older

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed , 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

Exclusion Criteria:

  1. Refusal to sign 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • General Population

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

    Other: There is no intervention in this study

Interventions

  • OtherThere is no intervention in this study

    There is no intervention in this study

06

What researchers measure

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.

    Time frame: One year

Secondary outcomes

  1. Validation of Sequencing Methods

    To validate the methods used to sequence samples

    Time frame: One year

07

Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
08

References and documents

Publications

  • 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. PubMed 33516247 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2020 (actual). Primary completion is estimated for Dec 2026, 80 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2020
First posted
Apr 24, 2020
StartActual
Apr 16, 2020
Primary completionEst.
Dec 30, 2026
CompletionEst.
Jul 31, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04359836
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Apr 24, 2020
Start date
Apr 16, 2020
Primary completion
Dec 30, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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