Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

NCT05178238 | Active Not Recruiting

• 1 other identifier: NIMAO/2021-1/AS-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

microbiota; gastrointestinal microbiome; translocation

Outcome Measures

Primary Outcomes (1)

• Number of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg)

  RT-qPCR of SARS-CoV-2 to calculate copies/mg

  Day 0

Secondary Outcomes (26)

• Age of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg)

  Day 0

• Sex of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg)

  Day 0

• Clinical features of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg)

  Day 0

• Total blood count of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg) if tested

  Day 0

• C-reactive protein level biological data of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg) if tested

  Day 0

Study Arms (2)

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

Other: Fecal sample

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

Other: Fecal sample

Interventions

Fecal sample OTHER

Fecal sample taken to investigate intestinal microbiota

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients hospitalized in the Nimes University Hoptial with SARS-CoV-2 infection confirmed by RT-PCR

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal and blood samples taken for a biobank

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Albert Sotto

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 5, 2022
• Study Start: January 11, 2022
• Primary Completion: January 9, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)