NCT06749483 The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?
| NCT ID | NCT06749483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jena University Hospital |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-27 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-27 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Johannes Ehler, Priv.-Doz. Dr. med.
PRINCIPAL INVESTIGATOR
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
Frequently Asked Questions
Who can join the NCT06749483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06749483 currently recruiting?
Yes, NCT06749483 is actively recruiting participants. Contact the research team at johannes.ehler@med.uni-jena.de for enrollment information.
Where is the NCT06749483 trial being conducted?
This trial is being conducted at Jena, Germany.
Who is sponsoring the NCT06749483 clinical trial?
NCT06749483 is sponsored by Jena University Hospital. The principal investigator is Johannes Ehler, Priv.-Doz. Dr. med. at Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital. The trial plans to enroll 100 participants.