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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	14 June 2021
Main ID:	NCT04913142
Date of registration:	31/05/2021
Prospective Registration:	Yes
Primary sponsor:	University Hospital, Toulouse
Public title:	About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. CO-MIC
Scientific title:	About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. (CO-MIC Study)
Date of first enrolment:	June 15, 2021
Target sample size:	60
Recruitment status:	Not yet recruiting
URL:	https://clinicaltrials.gov/show/NCT04913142
Study type:	Observational
Study design:
Phase:

Countries of recruitment
France

Contacts

Name:	Fanny BOUNES, MD, PhD
Address:
Telephone:	+33 5 61 32 23 11
Email:	bounes.f@chu-toulouse.fr
Affiliation:

Name:	Fanny BOUNES, MD
Address:
Telephone:	05 61 32 23 11
Email:	bounes.f@chu-toulouse.fr
Affiliation:

Name:	Fanny BOUNES, MD
Address:
Telephone:
Email:
Affiliation:	University Hospital, Toulouse

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

SARS-CoV-2 Acute Respiratory Disease

Intervention(s)

Other: Fecal and oral samples

Primary Outcome(s)

difference in bacterial DNA sequencing from oral and fecal samples [Time Frame: day 1]

difference in bacterial DNA sequencing from oral and fecal samples [Time Frame: day 14]

difference in bacterial DNA sequencing from oral and fecal samples [Time Frame: day 7]

Secondary Outcome(s)

Secondary ID(s)

2021-A00096-35

RC31/21/0019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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