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

NCT ID: NCT04913142

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2025-02-15

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.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control

patients not suffering from COVID-19 hospitalized in intensive care unit

Fecal and oral samples

Intervention Type: OTHER

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

Fecal and oral samples

Intervention Type: OTHER

oral and rectal swab from patients hospitalized at day 1, each 7 days and at the end of their ICU stay

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanny BOUNES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital of Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2021-A00096-35

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/21/0019

Identifier Type: -

Identifier Source: org_study_id