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Recruiting Observational

The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?

NCT06749483 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2024-12-27
Last updated
2024-12-30

Condition(s) studied

Critical IllnessIntensive Care Unit DeliriumNeurocognitive DeficitMicrobiome,immune Function, Critically IllInfection in ICUSepsis

Study summary

Here, the investigators propose to study host responses to reduced microbiome complexity driven by treatment with broad spectrum antibiotics in patients with severe infections or sepsis. The proposal aims to combine holistic approaches with emerging experimental technologies to investigate the complex interactions between the gut microbiota and its host and assess the impact of specific bacterial communities on longevity and stress responses. A strong focus of this study will also be placed on microbiome dysbiosis and secondary impacts on short- and long-term brain dysfunction using clinical, laboratory and imaging procedures.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * One of the following criteria 1. Critically ill patients treated with meropenem or piperacillin/tazobactam started within the last 72 h 2. Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days 3. Long-term survivors of sepsis, e.g. from pre-existing sepsis cohorts Exclusion Criteria: * Inflammatory bowel disease * Major bowel resection * Selective decontamination of the oral and digestive tract * Oral vancomycin therapy * Immunocompromised patients * History of chemotherapy during the last 6 months. * Known travel history to countries to areas of high antimicrobial resistance (\>5% according to the report of the European Centre for Disease Prevention and Control and all countries except USA and Canada) within the last 4 weeks * Acute neurological diseases (e.g., brain ischemia, hemorrhage, meningoencephalitis, tumor) * Manifest dementia, pre-existing psychiatric diseases (schizophrenia, psychosis) * Acute brain surgery * MRI contraindications: pacemakers, hearing aids, neurostimulation, insulin pumps, other potentially ferromagnetic implants, screws, clips, prostheses, metal splinters, etc., pregnancy, claustrophobia, extensive tattoos.

Primary outcome measure(s)

  • Number of patients with brain dysfunction — From enrollment to day 180
    Patients from all three groups will be assessed for microbiome dysbiosis (e.g. shotgun metagenomics), and for brain dysfunction (e.g. CAM-ICU, ICDSC, MoCa, MMST, neuropsychiatric examination, MRI).

Trial sites (1)

FacilityCityRegionStatus
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena Jena Thuringia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06749483 on ClinicalTrials.gov ↗ ← All trials in Germany