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Septic ShockIGA-TMNCT03861325

Acute Intestinal Failure in Critically Ill Patients and Microbial Translocation

An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The hypothesis of the investigators is that patients with septic shock in ICU have acute intestinal insufficiency favoring subclinical microbial translocation, which is the consequence of alterations of the epithelium, and is accompanied by qualitative and quantitative changes in the gut microbiota. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
How many people
60 participants
Where
1 siteFrance
Study dates
2 Apr 2019to 9 Sep 2020
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with septic shock

Who may be able to join

  • The patient or his / her representative has been informed about the implementation of the study, its objectives, its constraints, the rights of the patient and must have received the newsletter and no opposition of the study.
  • The patient must be an affiliate or beneficiary of a health insurance plan.
  • The patient is at least 18 years old.
  • The patient has septic shock as defined by the 3rd International Conference for the definition of sepsis and septic shock

Who cannot join

  • The patient is in an exclusion period determined by a previous study
  • The patient is under guardianship, under guardianship, or under the protection of justice
  • The patient has already participated in this study
  • The patient or his / her representative refuses to participate in the study
  • The patient is pregnant, parturient or is breastfeeding
  • The patient is a minor
Show all 11Show fewer
  • The patient is in therapeutic limitation or moribund
  • The patient has undergone or is going to have scheduled or emergency digestive surgery
  • The patient is HIV-positive
  • The patient has Child C cirrhosis
  • The patient has progressive digestive neoplasia, digestive lymphoma, chronic inflammatory bowel disease (Crohn's disease ...).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nimes University Hospital

    Nîmes, 30029

Other trials in France

About this study

Official title: Insuffisance Gastro-intestinale Aiguë Translocation Microbienne Chez Les Patients en Choc Septique : Une étude Pilote

The hypothesis of the investigators is that patients with septic shock in ICU have acute intestinal insufficiency favoring subclinical microbial translocation, which is the consequence of alterations of the epithelium, and is accompanied by qualitative and quantitative changes in the gut microbiota.

The primary objective is to determine the incidence of microbial translocation by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock.

Read more

Secondary objectives are:

  • Describe the kinetics of markers of intestinal insufficiency (I-FABP / zonulin) over time (at admission, 12 hours after admission, one day, two day, three days and seven day after admission).
  • Study the correlation between the titer of I-FABP, zonulin, 16srDNA, 18srDNA and the stages of acute gastrointestinal insufficiency (AGF).
  • Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbial translocation.
  • Study the possible correlations between the 16SrDNA levels and the other bacterial markers (sCD14, LBP).
  • Describe the evolution of the composition and the diversity of the gut microbiota in the first 7 days of septic shock
Read the detailed description

All eligible patients admitted for septic shock in resuscitation at Nimes will be included in the study, after verification of inclusion and non-inclusion criteria and with their agreement.

This is an observational study with no impact on the quality of care provided. All study data will be entered into an electronic CRF (e-CRF) directly or from the paper version of the scorecard.

The entry into the e-CRF is controlled and formatted to prohibit the input of out-of-bounds or outliers. In case of modification of data entry, traceability and monitoring of activities is ensured. An electronic signature committing the responsibility of the investigator of each center will allow the validation of the visit and the e-CRF.

Only those persons participating in the research project and identified will have access to the software allowing this entry: Redcap.

Redcap software that allows you to generate electronic CRFs (e-CRF), electronically capture data, manage it and restore it. It also makes it possible to follow the progress of studies in terms of data entry and to manage them. It is open source software that is extensible, modular and based on international standards.

Redcap software allows:

  • Data entry, validation and annotation by clinicians and research associates
  • Data extraction, filtering and analysis by investigators
  • Study management by study coordinators
  • Monitoring, auditing, configuration and reporting by administrators The electronic observation notebook creation software is hosted on a website within the CHU of Nîmes. Access to this application is secure and is via a password. Data collected through this software is backed up daily on a secure network. The network is connected to the internet, the access is protected by a firewall.

The clinical data of the study will be stored on a specific directory of the server. Only the network administrators and the authorized persons of the clinical research unit of the medical information department can have access to this directory.

IT arrangements made to enforce the confidentiality commitment

  • The technical resources are located in the IT department whose access is controlled and secure.
  • The data is stored on a server hosted in a secure room at the CHU Nîmes.
Conditions
Septic Shock
Keywords
acute gut failure
Medical subject headings
Shock, Septic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe the incidence of microbial translocation in critical illness by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock

    Plasma levels of circulating 16S rDNA and 18S rDNA will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission.

    Measured: 7 days

Secondary outcomes (5)

  1. Describe the kinetics of markers of intestinal insufficiency by measuring I-FABP and Zonulin plasma levels

    Plasma levels of I-FABP and Zonulin will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission.

    Measured: 7 days

  2. Study the correlation between the titer of I-FABP, zonulin, 16S rDNA, 18S rDNA and the stages of acute gastrointestinal insufficiency (AGF)

    Plasma levels of 16S rDNA, 18S rDNA, I-FABP and Zonulin will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission and stages of AGF will be evaluated at the same time.

    Measured: 7 days

  3. Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbila translocation

    the results of the qualitative analysis of the microbiota will be compared with the results of the classic microbiological samples taken on admission to the intensive care unit

    Measured: 7 days

  4. Study the possible correlations between the 16SrDNA plasma levels and the other bacterial markers (plasma levels of sCD14, LBP)

    Plasma levels of 16S rDNA, sCD14 and LBP will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission.

    Measured: 7 days

  5. Perform a qualitative and quantitative analysis of the intestinal microbiota at admission to intensive care and after 7 days from a stool sample taken on admission to intensive care on the seventh day after admission

    The metagenomic analysis of the gut microbiota is based on the high-throughput sequencing of all bacteria in a stool sample by targeting the 16S rRNA genes. The first step of this technique is to PCR amplify a 16S rDNA genomic target (eg V3-V4 regions) from stool sample DNA and to control the amplified sequences (called "libraries"). The second step consists in sequencing the libraries on a sequencing automaton. The bioinformatic analysis of the sequences consists of making a reference sequence library of the 16S rDNA target and aligning the sequences obtained with this database in order to establish lists of present organisms and taxonomic trees (OTU - operational taxonomic unit).

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start2 Apr 2019
  3. Primary completion9 Sep 2020
  4. Study completion9 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03861325
Sponsor's protocol ID
2018-A02192-53
Other IDs
2018-A02192-53
Acronym
IGA-TM
Status last verified
Dec 2020
First submitted
26 Feb 2019
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pansu N, Drakulovski P, Krasteva D, Bellet V, Lavigne JP, Dunyach-Remy C, Salipante F, Yahiaoui-Martinez A, Donnadieu-Rigole H, Bertout S. Detection of Fungal Translocation in Patients With Alcohol Use Disorder Using a Real-Time PCR Assay. APMIS. 2026 Mar;134(3):e70181. doi: 10.1111/apm.70181.

    PubMed 41839701

  • Magnan C, Lancry T, Salipante F, Trusson R, Dunyach-Remy C, Roger C, Lefrant JY, Massanet P, Lavigne JP. Role of gut microbiota and bacterial translocation in acute intestinal injury and mortality in patients admitted in ICU for septic shock. Front Cell Infect Microbiol. 2023 Dec 18;13:1330900. doi: 10.3389/fcimb.2023.1330900. eCollection 2023.

    PubMed 38179421

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the incidence of microbial translocation in critical illness by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861325, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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