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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05107245

Acronym

EDIFICE

Enrollment

143

Registered

2021-11-04

Start date

2020-04-28

Completion date

2021-05-31

Last updated

2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

microbiome ; SARS-CoV-2 ; metagenomic ; stool

Brief 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.

Interventions

DIAGNOSTIC_TEST1test1

Loss of bacterial diversity diagnosis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Alpha-diversity	at the time of inclusion in the study	Alpha-diversity of the gut microbiota measured by 16S sequencing

Secondary

Measure	Time frame	Description
SARS-CoV-2 load	at the time of inclusion in the study	SARS-CoV-2 load in stool measured by RT-PCR
Microbiome composition	at the time of inclusion in the study	Genus level of the gut microbiota measured by 16S sequencing

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026