Exploring the role of gut flora in COVID-19 infection
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
This study looks at whether the COVID-19 virus can be found in the stool of infected patients to better understand how it affects the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ProgenaBiome Academic / other |
| Locations | 1 site (Ventura, California) |
| Trial ID | NCT04359836 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate whether the SARS-CoV-2 virus, which causes COVID-19, is present in the stool of infected patients. Stool samples will be collected from individuals diagnosed with COVID-19 during their treatment and again after treatment to assess viral shedding. The study does not involve any interventions, focusing solely on the analysis of stool samples. By understanding the relationship between gut flora and COVID-19, the research may provide insights into the infection process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with COVID-19 within one week of screening.
Not a fit: Patients with a history of certain gastrointestinal surgeries or those receiving total parenteral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of COVID-19 transmission and its relationship with gut microbiome health.
How similar studies have performed: While studies on the gut microbiome's role in various infections exist, this specific investigation into COVID-19 and gut flora is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ventura, California
- ProgenaBiome — Ventura, California, United States (Recruiting)
Study contacts
- Principal investigator: Sabine Hazan, MD — ProgenaBiome
- Study coordinator: Sabine Hazan, MD
- Email: drsabinehazan@progenabiome.com
- Phone: 805-339-0549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.