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Completed

NCT Number: NCT05107245

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire Region, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1test1

Diagnostic Test

Loss of bacterial diversity diagnosis

Primary outcomes

  1. Alpha-diversity

    Time frame: at the time of inclusion in the study

    Alpha-diversity of the gut microbiota measured by 16S sequencing

Secondary outcomes

  1. SARS-CoV-2 load

    Time frame: at the time of inclusion in the study

    SARS-CoV-2 load in stool measured by RT-PCR

  2. Microbiome composition

    Time frame: at the time of inclusion in the study

    Genus level of the gut microbiota measured by 16S sequencing

Sponsors and collaborators

Lead sponsor

Luxia Scientific

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: EDIFICE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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