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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• COVID-19

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