Investigating the gut microbiome's role in sepsis and brain function in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how reduced microbiome complexity, due to broad-spectrum antibiotic treatment, affects critically ill patients with severe infections or sepsis. Researchers will collect stool, rectal swab, and plasma samples, alongside clinical and neuropsychological data, to assess the relationship between microbiome dysbiosis and brain dysfunction. The study will also analyze immune cell diversity and investigate the impact of specific bacterial communities on patient outcomes over time. By correlating metagenomic and metabolomic data with clinical results, the study seeks to uncover new insights into the gut-brain axis in critically ill patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
  Jena, Thuringia, Germany Recruiting

Study contacts

• Principal investigator: Johannes Ehler, Priv.-Doz. Dr. med. — Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
• Study coordinator: Johannes Ehler, Priv.-Doz. Dr. med.
• Email: johannes.ehler@med.uni-jena.de
• Phone: +49 36419323397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.