Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

NCT ID: NCT05178238

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-11

Study Completion Date

2026-06-30

Brief Summary

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The study investigators hypothesize that SARS-Cov2 infection alters the composition of the digestive microbiota and its functionality, resulting in changes in intestinal permeability and consequently in microbial digestive translocation. These changes may correlate with the magnitude of the SARS-CoV-2 viral load in the gastrointestinal tract and may have an impact on the clinical manifestations and evolvability of COVID-19.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with high viral load of SARS-CoV-2 in feces

Fecal sample

Intervention Type OTHER

Fecal sample taken to investigate intestinal microbiota

Patients with low viral load of SARS-CoV-2 in feces

Fecal sample

Intervention Type OTHER

Fecal sample taken to investigate intestinal microbiota

Interventions

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Fecal sample

Fecal sample taken to investigate intestinal microbiota

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient hospitalized at in Nimes University hospital
* Infection with SARS-CoV-2 confirmed by RT-PCR
* The patient must have signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria

* The subject is participating in an interventional study susceptible to modify the intestinal microbiota, or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient with a chronic digestive pathology or having been operated in the previous year or having enteral nutrition or having had bariatric surgery
* Patient is pregnant, parturient or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Sotto

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2021-1/AS-01

Identifier Type: -

Identifier Source: org_study_id

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