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

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ClinicalTrials.gov Identifier: NCT04359836
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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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.

Condition or disease Intervention/treatment
Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19 Coronavirus-19 COVID 19 Other: There is no intervention in this study

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : July 31, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
General Population
The general population will have their microbiome sequenced from stool samples provided.
 Other: There is no intervention in this study
There is no intervention in this study


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: One year ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults 18 and older
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359836


Contacts
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Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04359836    
Other Study ID Numbers: PRG-041
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ProgenaBiome:
Microbiome
Coronavirus
Corona Virus
 19
COVID
COVID-19
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases