Critical IllnessMS-ICUNCT06749483
The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?
An observational study of Critical Illness and Intensive Care Unit Delirium, run by Jena University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care Unit Delirium, Neurocognitive Deficit
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 27 Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients with and without antibiotic treatment as well as patients with long-term survival after critical illness
Who may be able to join
- Age ≥ 18 years
- One of the following criteria
- Critically ill patients treated with meropenem or piperacillin/tazobactam started within the last 72 h
- Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days
- Long-term survivors of sepsis, e.g. from pre-existing sepsis cohorts
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
Jena, Thuringia, 07747
Johannes Ehler, Priv.-Doz. Dr. med., +49 3641-9-323397, johannes.ehler@med.uni-jena.de
Katrin Ludewig, Dr. med., +4936419323378, katrin.ludewig@med.uni-jena.de
About this study
Official title: The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? Research on Human Tissue, Body Fluids, Neuropsychological Assessment and Brain Imaging
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.
Read the detailed description
Prospective observational study to obtain faeces, rectal swabs, and plasma samples from critically ill patients with and without broad spectrum antimicrobial therapy as well as from long-term survivors after sepsis. Furthermore, clinical, neuropsychological and neuroimaging data will be collected to assess short- and long-term brain dysfunction.
Furthermore it will be to correlate metagenomic and metabolomic data analysis from stool and blood samples of ICU patients with clinical outcomes (including the trajectory of neuro-cognitive deficits) and stress-related parameters.
Additionally, the study aims to identify if microbiome dysbiosis is connected to short- and long-term brain dysfunction and to assess which microbiome metabolic products influence brain dysfunction.
Moreover, the investigators aim to explore immune cell diversity through single cell whole transcriptome analysis in order to establish new hypotheses on specific bacteria species and metabolites to affect the immune cell type composition of patients (single cell immuno-profiling) and integrate single cell RNA sequencing with clinical symptoms in critically ill patients.
Finally, the question is addressed whether there are differences between blood cell composition and activation between younger and older patients with and without sepsis.
In this regard, blood- and stool samples will be taken from participants at five time points as follows: three time points during ICU treatment respectively (at study inclusion day 1, day 7 and day 14) and as well as two follow-up surveys (3 and 6 months after inclusion). Brain dysfunction will be assed by daily delirium screening tests (CAM-ICU and ICDSC) and at the time of discharge from hospital by MoCa and Mini Mental Status Examination. At the follow-up survey functional MRI as well as neuropsychological measures will be performed.
- Conditions
- Critical Illness, Intensive Care Unit Delirium, Neurocognitive Deficit, Microbiome,immune Function, Critically Ill, Infection in ICU, Sepsis
- Keywords
- sepsis, broad-spectrum antibiotics, stool, neuropsychological assessment, delirium, neurocognitive impairment, microbiome
- Medical subject headings
- Critical Illness, Sepsis, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with antibiotic treatment | ICU patients treated with piperacillin/tazobactam or meropenem | |
| ICU patients without antibiotic treatment | ICU patients without antibiotic treatment during their ICU stay | |
| Long-term survivors of critical illness | Long-term survivors at least six months or more after the beginning of critical illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with brain dysfunction
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).
Measured: From enrollment to day 180
Secondary outcomes (4)
Number of patients with survival
Measured: From enrollment to the end of study at 180 days
Days on the ICU
Measured: From enrollment to the end of study at 180 days
Days on the respirator
Measured: From enrollment to the end of study at 180 days
Days with vasopressor support
Measured: From enrollment to the end of study at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start27 Dec 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Responsible party
- Principal investigator, Johannes Ehler, Jena University Hospital
- Investigators
- Johannes Ehler, Priv.-Doz. Dr. med., Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749483
- Sponsor's protocol ID
- 2024-3429-BO
- Acronym
- MS-ICU
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruhlmann M, Xu L, Bauer M, Lehmann T, Panagiotou G, Neugebauer S, Kiehntopf M, Klawitter F, Ehler J. Correlation of brain injury biomarkers with brain dysfunction, brain injury, and outcomes in critically ill patients: a post hoc exploratory analysis. Infection. 2026 Jun;54(3):1501-1517. doi: 10.1007/s15010-026-02790-2. Epub 2026 Apr 13.
PubMed 41973367
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? Research on Human Tissue, Body Fluids, Neuropsychological Assessment and Brain Imaging
- ClinicalTrials.gov ID
- NCT06749483
- Acronym / sponsor ID
- MS-ICU / 2024-3429-BO
- Conditions
- Critical Illness, Intensive Care Unit Delirium, Neurocognitive Deficit, Microbiome,immune Function, Critically Ill, Infection in ICU, Sepsis
- Keywords
- sepsis, broad-spectrum antibiotics, stool, neuropsychological assessment, delirium, neurocognitive impairment, microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective observational study to obtain faeces, rectal swabs, and plasma samples from critically ill patients with and without broad spectrum antimicrobial therapy as well as from long-term survivors after sepsis. Furthermore, clinical, neuropsychological and neuroimaging data will be collected to assess short- and long-term brain dysfunction.
Furthermore it will be to correlate metagenomic and metabolomic data analysis from stool and blood samples of ICU patients with clinical outcomes (including the trajectory of neuro-cognitive deficits) and stress-related parameters.
Additionally, the study aims to identify if microbiome dysbiosis is connected to short- and long-term brain dysfunction and to assess which microbiome metabolic products influence brain dysfunction.
Moreover, the investigators aim to explore immune cell diversity through single cell whole transcriptome analysis in order to establish new hypotheses on specific bacteria species and metabolites to affect the immune cell type composition of patients (single cell immuno-profiling) and integrate single cell RNA sequencing with clinical symptoms in critically ill patients.
Finally, the question is addressed whether there are differences between blood cell composition and activation between younger and older patients with and without sepsis.
In this regard, blood- and stool samples will be taken from participants at five time points as follows: three time points during ICU treatment respectively (at study inclusion day 1, day 7 and day 14) and as well as two follow-up surveys (3 and 6 months after inclusion). Brain dysfunction will be assed by daily delirium screening tests (CAM-ICU and ICDSC) and at the time of discharge from hospital by MoCa and Mini Mental Status Examination. At the follow-up survey functional MRI as well as neuropsychological measures will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICU patients with antibiotic treatment | – | –ICU patients treated with piperacillin/tazobactam or meropenem |
| ICU patients without antibiotic treatment | – | –ICU patients without antibiotic treatment during their ICU stay |
| Long-term survivors of critical illness | – | –Long-term survivors at least six months or more after the beginning of critical illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with and without antibiotic treatment as well as patients with long-term survival after critical illness
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- One of the following criteria
Key exclusion criteria (11 listed)
- Inflammatory bowel disease
- Major bowel resection
- Selective decontamination of the oral and digestive tract
- Oral vancomycin therapy
- Immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with brain dysfunction
Time frame: 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).
4 secondary outcomes
Number of patients with survival
Time frame: From enrollment to the end of study at 180 days
Days on the ICU
Time frame: From enrollment to the end of study at 180 days
Days on the respirator
Time frame: From enrollment to the end of study at 180 days
Days with vasopressor support
Time frame: From enrollment to the end of study at 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 41973367Ruhlmann M, Xu L, Bauer M, Lehmann T, Panagiotou G, Neugebauer S, Kiehntopf M, Klawitter F, Ehler J. Correlation of brain injury biomarkers with brain dysfunction, brain injury, and outcomes in critically ill patients: a post hoc exploratory analysis. Infection. 2026 Jun;54(3):1501-1517. doi: 10.1007/s15010-026-02790-2. Epub 2026 Apr 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Ehler, Priv.-Doz. Dr. med. principal investigator
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Intensive Care Unit Delirium, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Ehler, Priv.-Doz. Dr. med. (+49 36419323397, johannes.ehler@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with brain dysfunction (time frame: From enrollment to day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.