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Acute Intestinal Failure in Critically Ill Patients and Microbial Translocation

NCT03861325 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-15

No results posted yet for this study

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.

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.

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

Conditions

  • Septic Shock

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2020-09-09
Completion
2020-09-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861325 on ClinicalTrials.gov