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NCT05178238 Clinical Trial

Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

COVID-19 Clinical Trial

— MICRODIGCOV  

Official title:
Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05178238
Other study ID # NIMAO/2021-1/AS-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 11, 2022
Est. completion date January 2025

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date January 2025
Est. primary completion date January 9, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fecal sample
Fecal sample taken to investigate intestinal microbiota

Locations
Country Name City State
France CHU de Nimes Nîmes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Age of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Age in years Day 0
Secondary Sex of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Male/female Day 0
Secondary Clinical features of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Date of start of symptoms, current therapeutics, antibiotic therapy, blood pressure, heart rate, respiration rate, oxygen saturation, symptoms, Covid stage (ordinal 8 stage scale) Day 0
Secondary 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 lymphocyte count, eosinophil count Day 0
Secondary 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 concentration Day 0
Secondary Fibrinogen level of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested concentration Day 0
Secondary Lactate Dehydrogenase of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested concentration Day 0
Secondary D-dimer level of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested concentration Day 0
Secondary Ferritin levels, of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested Concentration Day 0
Secondary Albumin levels of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) concentration Day 0
Secondary Calcium levels of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested concentration Day 0
Secondary Glomerular filtration rate of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) if tested volume per time Day 0
Secondary Liver function tests 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
Secondary Cytobacteriological urine exam 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
Secondary Blood cultures 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
Secondary Other infectious samples (other than SARS-CoV-2) 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
Secondary Taxonomic features of intestinal microbiota of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Number of Operational Taxonomic Unit Day 0
Secondary Percentage of Operational Taxonomic Units in intestinal microbiota of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Day 0
Secondary Diversity of intestinal microbiota of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Shannon Index Day 0
Secondary Diversity of intestinal microbiota of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) Bray Curtis Index Day 0
Secondary LPS-binding Protein concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) pg/ml ELISA Day 0
Secondary soluble CD14 concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) ng/ml ELISA Day 0
Secondary RNA16s concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) PCR and sequencing Day 0
Secondary RNA18 concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) PCR and sequencing Day 0
Secondary I-FAB concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) ng/ml:ELISA Day 0
Secondary Claudin 3 concentration of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (=50 copies/mg) ng/ml:ELISA Day 0
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