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

NCT04913142 | Withdrawn

• 2 other identifiers: RC31/21/00192021-A00096-35
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Keywords

SARS-CoV-2; COVID 19; Critical care; microbiota; microbiome

Outcome Measures

Primary Outcomes (3)

• 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

  day 1

• 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

  day 7

• 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

  day 14

Study Arms (2)

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

Fecal and oral samples OTHER

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

control; patients COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients hospitalized in intensive care units (ICU)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal and oral samples will be collected in each patient at the admission in intensive care unit to analyze bacterial DNA and describe their microbiota

MeSH Terms

Conditions

COVID-19

Interventions

Defecation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Fanny BOUNES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: June 15, 2021
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)