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

December 17, 2021 updated by: Luxia Scientific

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pays De La Loire
      • Nantes, Pays De La Loire, France, 44093
        • Centre Hospitalier Universitaire De Nantes
    • Seine-et-Marne
      • Fontainebleau, Seine-et-Marne, France, 77300
        • Centre Hospitalier de Fontainebleau
    • Seine-et-marne
      • Melun, Seine-et-marne, France, 77000
        • Clinique Saint Jean l'Ermitage
    • Île De France
      • Évry-Courcouronnes, Île De France, France, 91000
        • Clinique Du Mousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 patients
Hospitalised COVID-19 patients
Diagnostic test: 1test1
Loss of bacterial diversity diagnosis
Controls
Exposed medical staff
Diagnostic test: 1test1
Loss of bacterial diversity diagnosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxia Scientific

Collaborators

Nantes University Hospital
Clinique Saint Jean Ermitage
Centre Hospitalier de Fontainebleau
Clinique du Mousseau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00979-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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