Intestinal Microbiota of Patients Hospitalized With Sars-... | NCT05178238

Studies
Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

NCT05178238

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Active, not recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

15Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Fecal sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2022Actual

Primary Completion Date

Jan 9, 2024Actual

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 18, 2021

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study investigators hypothesize that SARS-Cov2 infection alters the composition of the digestive microbiota and its functionality, resulting in changes in intestinal permeability and consequently in microbial digestive translocation. These changes may correlate with the magnitude of the SARS-CoV-2 viral load in the gastrointestinal tract and may have an impact on the clinical manifestations and evolvability of COVID-19.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with high viral load of SARS-CoV-2 in feces			Other: Fecal sample
Patients with low viral load of SARS-CoV-2 in feces			Other: Fecal sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal sample	Other	Fecal sample taken to investigate intestinal microbiota	Patients with high viral load of SARS-CoV-2 in feces Patients with low viral load of SARS-CoV-2 in feces

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg)	RT-qPCR of SARS-CoV-2 to calculate copies/mg	Day 0

Secondary Outcomes

Measure	Description	Time Frame
Age of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg)	Age in years	Day 0
Sex of patients with high viral load of SARS-CoV-2 in feces (>50 copies/mg) versus low viral load (≤50 copies/mg)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient hospitalized at in Nimes University hospital
Infection with SARS-CoV-2 confirmed by RT-PCR
The patient must have signed the consent form
The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

The subject is participating in an interventional study susceptible to modify the intestinal microbiota, or is in a period of exclusion determined by a previous study
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Patient with a chronic digestive pathology or having been operated in the previous year or having enteral nutrition or having had bariatric surgery
Patient is pregnant, parturient or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult patients hospitalized in the Nimes University Hoptial with SARS-CoV-2 infection confirmed by RT-PCR

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Albert Sotto	CHU Nimes	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided