About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. (CO-MIC)

About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. (CO-MIC Study)

The objective of the present study is to describe the negative impact on oral and gut microbiota of a severe acute respiratory syndrome SARS-CoV-2 infection in patients hospitalized in intensive care units (ICU). The study would like to compare their microbiota to the microbiota of ICU patients, non-infected by the SARS-CoV-2.

Study Overview

• Status: Withdrawn
• Conditions: SARS-CoV-2 Acute Respiratory Disease
• Intervention / Treatment: Other: Fecal and oral samples

Detailed Description

Gut microbiota in ICU patients is sorely distorted, there is an important loss of diversity which can be traduced by a decrease of commensal bacteria and an increase of pathogens. The virulence, infectivity, and transmissibility of the emerging SARS-Coronavirus 2 is a reason for us to find strategies and therapeutics to curb the epidemic. Gut mucosa is very probably a target for the virus and it seems likely that feces are a way of transmissibility. It suppose too that gut microbiota is more weathered in patients with a SARS-CoV-2 infection, moreover if they have to be hospitalized in ICU. For this reason, the present study would like to collect oral and rectal swab from patients hospitalized in ICU for a serious SARS-CoV-2 infection and from patients hospitalized in ICU for another reason that a SARS-CoV-2 infection at day 1, each 7 days and at the end of their ICU stay. Other objectives are to know if this distorted microbiota is a risk factor for poor outcomes in our ICU patients, if antibiotics and artificial nutrition are too a risk factor of weathered microbiota and finally if we can connect oral and rectal dysbiosis to use the oral dysbiosis to predict the rectal dysbiosis in view of the ease to collect oral sample.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients hospitalized in intensive care units (ICU)

Description

Inclusion Criteria:

Controls:

- Hospitalized patient with non-SARS-CoV-2 hypoxemic pneumonia

Patients COVID 19:

- Patient hospitalized for SARS-CoV-2 hypoxemic pneumonia

All:

• Patient hospitalized for less than 48 hours in a general intensive care unit
• Patient who has given free, informed and express (oral) consent to participate in the research (or a close relative or trusted person of the patient if the patient cannot express himself/herself)
• Patient covered by a social security system or equivalent
• Expected hospitalization of more than 48 hours

Exclusion Criteria:

• gut inflammatory disease
• recent gut surger
• ostomy
• recent antibiotics
• artificial nutrition in the long term

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; patients not suffering from COVID-19 hospitalized in intensive care unit	Other: Fecal and oral samples; oral and rectal swab from patients hospitalized at day 1, each 7 days and at the end of their ICU stay
patients COVID-19; patients suffering from COVID-19 hospitalized in intensive care unit	Other: Fecal and oral samples; oral and rectal swab from patients hospitalized at day 1, each 7 days and at the end of their ICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constitution of the oral and faecal microbiota obtained by sequencing of bacterial DNA	measuring the difference in bacterial DNA sequencing from oral and fecal samples among ICU patients infected by the SARS-CoV-2 and ICU patients without SARS-CoV-2 at day 1	day 1
Measuring the difference in bacterial DNA sequencing from oral and fecal samples of patients infected by the SARS-COV-2 and patient without SARS-COV-2 at day 7	Measuring difference in bacterial DNA sequencing from oral and fecal samples among ICU patients infected by the SARS-CoV-2 and ICU patients without SARS-CoV-2	day 7
Measuring the difference in bacterial DNA sequencing from oral and fecal samples of patient infected by the SARS-COV-2 and patient without SARS-COV-2 at day 14	difference in bacterial DNA sequencing from oral and fecal samples among ICU patients infected by the SARS-CoV-2 and ICU patients without SARS-CoV-2	day 14

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fanny BOUNES, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID 19; Critical care; microbiome; microbiota
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: RC31/21/0019; 2021-A00096-35 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No