Investigating the gut microbiome's role in sepsis and brain function in critically ill patients
The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? Research on Human Tissue, Body Fluids, Neuropsychological Assessment and Brain Imaging
This study is trying to see how changes in gut bacteria from antibiotic use affect brain function and recovery in critically ill patients with severe infections or sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jena, Thuringia) |
| Trial ID | NCT06749483 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients aged 18 and older receiving specific antibiotic treatments or those expected to stay in the ICU for more than three days.
Not a fit: Patients with inflammatory bowel disease, major bowel resection, or acute neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sepsis-related brain dysfunction in critically ill patients.
How similar studies have performed: While the approach of linking microbiome analysis to brain function in critically ill patients is innovative, similar studies have shown promising results in understanding the gut-brain connection.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jena, Thuringia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.