A Study to Explore the Role of Gut Flora in COVID-19 Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There is no intervention in this study.
- Who it may be relevant to
- Registry conditions: Gut Microbiome, Gastrointestinal Microbiome, COVID, COVID-19. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
Overview
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
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.
Interventions
- Other There is no intervention in this study
There is no intervention in this study
Primary outcome measures
- Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [Time frame: One year]
Secondary outcome measures (1)
- Validation of Sequencing Methods [Time frame: One year]
Eligibility criteria
Inclusion criteria
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Male or female of 18 years of age or older
- Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening
Exclusion criteria
- Refusal to sign informed consent form
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Treatment with total parenteral nutrition
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- ProgenaBiome — Ventura
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. PMID 33516247
Identifiers
NCT: NCT04359836 · PRG-041