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

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

— CO-MIC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04913142
• Other study ID #: RC31/21/0019
• Secondary ID: 2021-A00096-35
• Status: Withdrawn
• Start date: June 15, 2021
• Est. completion date: February 15, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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