Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359836
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 msjordandaniels@gmail.com

Locations
Layout table for location information
United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    sabinehazan@aim.com   
Contact: Jordan Daniels, MS    805-339-0549    msjordandaniels@gmail.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
Layout table for investigator information
Principal Investigator: Sabine Hazan, MD ProgenaBiome
Layout table for additonal information
Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04359836    
Other Study ID Numbers: PRG-041
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases