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NCT05107245 Clinical Trial

Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.

COVID-19 Clinical Trial

— EDIFICE  

Official title:
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05107245
Other study ID # 2020-A00979-30
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date May 31, 2021

Study information
Verified date December 2021
Source Luxia Scientific
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date May 31, 2021
Est. primary completion date April 29, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample. - Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients. - Aged between 18 and 95 years. - Subjects able to read the French-language study information leaflet. - Patients with social cover. Exclusion Criteria: - COVID-19 negative patients. - Patients in critical care, heart failure or respiratory failure. - Unable to provide naturally a stool sample. - Patients without social cover. - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 1test1
Loss of bacterial diversity diagnosis

Locations
Country Name City State
France Clinique du Mousseau Évry-Courcouronnes Île De France
France Centre Hospitalier de Fontainebleau Fontainebleau Seine-et-Marne
France Clinique Saint Jean l'Ermitage Melun Seine-et-marne
France Centre Hospitalier Universitaire de Nantes Nantes Pays De La Loire

Sponsors (5)
Lead Sponsor Collaborator
Luxia Scientific Centre Hospitalier de Fontainebleau, Clinique du Mousseau, Clinique Saint Jean Ermitage, Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alpha-diversity Alpha-diversity of the gut microbiota measured by 16S sequencing at the time of inclusion in the study
Secondary SARS-CoV-2 load SARS-CoV-2 load in stool measured by RT-PCR at the time of inclusion in the study
Secondary Microbiome composition Genus level of the gut microbiota measured by 16S sequencing at the time of inclusion in the study
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