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NCT04359836 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04359836
Other study ID # PRG-041
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date July 31, 2025

Study information
Verified date September 2021
Source ProgenaBiome
Contact Sabine Hazan, MD
Phone 805-339-0549
Email drsabinehazan@progenabiome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 31, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• There is no intervention in this study
There is no intervention in this study

Locations
Country Name City State
United States ProgenaBiome Ventura California

Sponsors (1)
Lead Sponsor Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Validation of Sequencing Methods To validate the methods used to sequence samples One year
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