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

T

Toulouse University Hospital

Status

Withdrawn

Conditions

SARS-CoV-2 Acute Respiratory Disease

Treatments

Other: Fecal and oral samples

Study type

Observational

Funder types

Other

Identifiers

NCT04913142
RC31/21/0019
2021-A00096-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

control
Description:
patients not suffering from COVID-19 hospitalized in intensive care unit
Treatment:
Other: Fecal and oral samples
patients COVID-19
Description:
patients suffering from COVID-19 hospitalized in intensive care unit
Treatment:
Other: Fecal and oral samples

Trial contacts and locations

1

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Central trial contact

Fanny BOUNES, MD

Data sourced from clinicaltrials.gov

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