Clinical trial NCT04913142: About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact.
Official title: About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. (CO-MIC Study)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: SARS-CoV-2 Acute Respiratory Disease
Keywords: SARS-CoV-2
COVID 19
Critical care
microbiota
microbiome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized in intensive care units (ICU)

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constitution of the oral and faecal microbiota obtained by sequencing of bacterial DNA
timeFrame: day 1
measure: 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
timeFrame: day 7
measure: 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
timeFrame: day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny BOUNES, MD
role: PRINCIPAL_INVESTIGATOR
References: