Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

N/AActive Not RecruitingNCT05178238

Centre Hospitalier Universitaire de Nīmes15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19

Interventions

Fecal sampleOTHER

Fecal sample taken to investigate intestinal microbiota

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nimes

Nîmes, France

Outcomes

Primary Outcomes

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

Time frame: Day 0

Secondary Outcomes

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

Time frame: 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)

Male/female

Time frame: 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)

Date of start of symptoms, current therapeutics, antibiotic therapy, blood pressure, heart rate, respiration rate, oxygen saturation, symptoms, Covid stage (ordinal 8 stage scale)

Time frame: 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

lymphocyte count, eosinophil count

Time frame: 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

concentration

Time frame: Day 0

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

Time frame: Day 0

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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)

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0