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WithdrawnNCT04913142CO-MICUpdated Oct 17, 2023

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

An observational study in SARS-CoV-2 Acute Respiratory Disease, sponsored by University Hospital, Toulouse. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by University Hospital, Toulouse · Observational

Why this study was withdrawn
No more COVID+ patients to enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • SARS-CoV-2 Acute Respiratory Disease

Keywords

  • SARS-CoV-2
  • COVID 19
  • Critical care
  • microbiota
  • microbiome
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients hospitalized in intensive care units (ICU)

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

Exclusion Criteria:

  • gut inflammatory disease
  • recent gut surger
  • ostomy
  • recent antibiotics
  • artificial nutrition in the long term
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • control

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

    Other: Fecal and oral samples

  • patients COVID-19

    patients suffering from COVID-19 hospitalized in intensive care unit

    Other: Fecal and oral samples

Interventions

  • OtherFecal and oral samples

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 1

  2. 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

    Time frame: day 7

  3. 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

    Time frame: day 14

07

Study locations

1 site
  • University Hospital of Toulouse
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04913142
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Jun 15, 2021
Primary completion
Feb 15, 2025 (estimated)
Completion
Feb 15, 2025 (estimated)
Last update
Oct 17, 2023

Study contacts

Fanny BOUNES, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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