Intestinal Microbiota Between Different GroupsNEUROBIOTENCT07058961
Study of the Intestinal Microbiota
An observational study of Intestinal Microbiota Between Different Groups, run by University Hospital, Rouen at 1 site in France.
Trial summary
The intestinal microbiota is the set of numerous microorganisms (between 1012 and 1014 bacteria, viruses, parasites, and non-pathogenic fungi) that live in our digestive tract, mainly in the small intestine and colon. Like a fingerprint, the intestinal microbiota is unique to each individual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Microbiota Between Different Groups
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to 1 Jun 2026
- How long will I take part?
- 28 Days
- 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: Any adult patient admitted to neurosurgical or surgical intensive care for severe brain injury, traumatic or not, requiring intubation, eligible for indirect calorimetry measurements, and whose expected length of stay is > 48 hours and Any adult patient admitted to surgical intensive care for multiple trauma without associated brain injury and/or for shock (hemorrhagic or septic*) and whose expected length of stay is > 48 hours.
Who may be able to join
- Brain-injured patient group: Any adult patient admitted to neurosurgical or surgical intensive care for severe brain injury, traumatic or not, requiring intubation, eligible for indirect calorimetry measurements, and whose expected length of stay is > 48 hours.
- Control group: Any adult patient admitted to surgical intensive care for multiple trauma without associated brain injury and/or for shock (hemorrhagic or septic) and whose expected length of stay is > 48 hours.
Who cannot join
- Refusal to participate in the study (request of non-opposition from relatives if the patient is unfit)
- Lack of social security affiliation;
- Minor patient;
- Patient under legal protection (guardianship or guardianship);
- Pregnant woman;
- Moribund patient or whose expected length of stay is ≤ 48 hours;
- Contraindication to indirect calorimetry (high FiO2, etc.);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Services de Réanimation Chirurgicale Et Réanimation Neurochirurgicale
Rouen, 76100
Emilie EO OCCHIALI, Doctor, 02 32 88 17 29 ext. +33, emilie.occhiali@chu-rouen.fr
About this study
Official title: Study of the Intestinal Microbiota of Patients Admitted to Intensive Care for Severe Brain Injury.
The intestinal microbiota is the set of numerous microorganisms (between 1012 and 1014 bacteria, viruses, parasites, and non-pathogenic fungi) that live in our digestive tract, mainly in the small intestine and colon. Like a fingerprint, the intestinal microbiota is unique to each individual. However, there is a common core of 15-20 species present in all humans, responsible for the essential functions of the microbiota.
Recent techniques for high-throughput sequencing of genetic material and metabolomics (i.e., the global analysis of the elements produced by the microbiota) have made it possible to more precisely describe the relationships between microorganisms and the host and how each influences the functioning of the body. Thus, we now know that the microbiota plays a role in digestive, metabolic, immune, and neurological functions. Certain events will modify the microbiota in a more or less lasting way: illnesses, medical treatments, diet, lifestyle. And these changes to the microbiota can, in turn, influence the body's behavior. As a result, dysbiosis-a quantitative, qualitative, or functional alteration of the microbiota-is a serious avenue for explaining certain pathologies.
This topic has become central to biological and medical research, as evidenced by the growing number of scientific publications since the 2010s. Scientists are trying to explore the bidirectional links between dysbiosis and pathologies. They are also trying to explore therapeutic avenues: how to modulate the microbiota to maintain it, bring it closer to, or restore its "normal" configuration to limit the impact of dysbiosis? Research has yielded encouraging results: fecal transplantation (instilling a sample of normal microbiota from the feces of healthy donors into a sick person) or new-generation probiotics with protective biological effects.
Read the detailed description
New research data have so far failed to find concrete resonance in intensive care patients, even though this highly stressed population is subjected to harmful pressure on the microbiota: antibiotics, gastric acid inhibitors, artificial nutrition, and sedative drugs that inhibit peristalsis. Studies remain conflicting, and this lack of evidence limits the development of targeted therapies for intensive care patients. The reason lies in the fact that there is no such thing as "one" intensive care patient, but rather different profiles depending on the type and level of stress, whether or not there is a surgical insult, the route of artificial nutrition administration, and the duration of antibiotic therapy. It is therefore necessary to conduct a comprehensive assessment. This essential preliminary information will ultimately aid in the development of targeted therapies designed to restore the microbiota and hopefully improve patient prognosis. This NEUROBIOTE study is part of this research framework and aims to explore the microbiota of a homogeneous category of patients: those admitted to surgical or neurosurgical intensive care for brain injury, whether traumatic or not, and for serious brain injury (i.e., requiring intubation). During the first phase of the study, the microbiota mapping of these patients, obtained after analysis of admission stools by rectal swab, was compared with that of a "control" group: patients admitted to surgical intensive care for multiple trauma without associated brain injury or for any state of shock requiring mechanical ventilation. During the second phase, changes in the microbiota of the "brain-injured patients" group during the first week of care, in light of the evolution of various factors: nutritional support, energy metabolism using indirect calorimetry, and markers of organ failure, will be analyzed.
This pilot study will lay the groundwork for those aiming to study other specific ICU populations.
- Keywords
- brain-damaged patients
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 |
|---|---|---|
| Patients admitted to surgical intensive care | Not described | |
| Patients admitted to neurosurgical intensive care for serious brain injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the intestinal microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury based on analysis of admission stools by rectal swab.
Analysis of the intestinal microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury using metagenomics (composition and diversity).
Measured: At Enrollment visit and Day 28
Secondary outcomes (4)
To compare the microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury with that of patients with multiple trauma and/or shock.
Analysis of the intestinal microbiota of patients admitted to surgical intensive care for multiple trauma and/or shock requiring mechanical ventilation based on analysis of admission stools.
Measured: At enrolment visit and Day 28
To analyze the changes in the intestinal microbiota of these patients as a function of nutritional interventions.
Analysis of the evolution of the microbiota of patients admitted to surgical intensive care for severe brain injury during the first week of hospitalization in relation to the modalities of nutritional support (calorie intake, types and routes of administration of artificial nutrition).
Measured: Day 7
To analyze the changes in the intestinal microbiota of these patients as a function of anti-infectious therapies.
Analysis of the evolution of the microbiota of patients admitted to surgical intensive care for severe brain injury during the first week of hospitalization in relation to the modalities of anti-infectious treatment (surgical techniques and drug treatment).
Measured: Day 7
To analyze the links between these modifications and the evolution of organ failures during the first week of hospitalization.
Evaluation of the link between evolution of the microbiota and evolution of the organ failure score (SOFA).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start28 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Microbiota Between Different GroupsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie EO OCCHIALI, Doctor, Study director, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058961
- Sponsor's protocol ID
- 2023/0214/OB
- Other IDs
- N° IDRCB : 2023-A02007-38
- Acronym
- NEUROBIOTE
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Intestinal Microbiota of Patients Admitted to Intensive Care for Severe Brain Injury.
- ClinicalTrials.gov ID
- NCT07058961
- Acronym / sponsor ID
- NEUROBIOTE / 2023/0214/OB
- Keywords
- brain-damaged patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
The intestinal microbiota is the set of numerous microorganisms (between 1012 and 1014 bacteria, viruses, parasites, and non-pathogenic fungi) that live in our digestive tract, mainly in the small intestine and colon. Like a fingerprint, the intestinal microbiota is unique to each individual. However, there is a common core of 15-20 species present in all humans, responsible for the essential functions of the microbiota.
Recent techniques for high-throughput sequencing of genetic material and metabolomics (i.e., the global analysis of the elements produced by the microbiota) have made it possible to more precisely describe the relationships between microorganisms and the host and how each influences the functioning of the body. Thus, we now know that the microbiota plays a role in digestive, metabolic, immune, and neurological functions. Certain events will modify the microbiota in a more or less lasting way: illnesses, medical treatments, diet, lifestyle. And these changes to the microbiota can, in turn, influence the body's behavior. As a result, dysbiosis-a quantitative, qualitative, or functional alteration of the microbiota-is a serious avenue for explaining certain pathologies.
This topic has become central to biological and medical research, as evidenced by the growing number of scientific publications since the 2010s. Scientists are trying to explore the bidirectional links between dysbiosis and pathologies. They are also trying to explore therapeutic avenues: how to modulate the microbiota to maintain it, bring it closer to, or restore its "normal" configuration to limit the impact of dysbiosis? Research has yielded encouraging results: fecal transplantation (instilling a sample of normal microbiota from the feces of healthy donors into a sick person) or new-generation probiotics with protective biological effects.
Detailed description
New research data have so far failed to find concrete resonance in intensive care patients, even though this highly stressed population is subjected to harmful pressure on the microbiota: antibiotics, gastric acid inhibitors, artificial nutrition, and sedative drugs that inhibit peristalsis. Studies remain conflicting, and this lack of evidence limits the development of targeted therapies for intensive care patients. The reason lies in the fact that there is no such thing as "one" intensive care patient, but rather different profiles depending on the type and level of stress, whether or not there is a surgical insult, the route of artificial nutrition administration, and the duration of antibiotic therapy. It is therefore necessary to conduct a comprehensive assessment. This essential preliminary information will ultimately aid in the development of targeted therapies designed to restore the microbiota and hopefully improve patient prognosis. This NEUROBIOTE study is part of this research framework and aims to explore the microbiota of a homogeneous category of patients: those admitted to surgical or neurosurgical intensive care for brain injury, whether traumatic or not, and for serious brain injury (i.e., requiring intubation). During the first phase of the study, the microbiota mapping of these patients, obtained after analysis of admission stools by rectal swab, was compared with that of a "control" group: patients admitted to surgical intensive care for multiple trauma without associated brain injury or for any state of shock requiring mechanical ventilation. During the second phase, changes in the microbiota of the "brain-injured patients" group during the first week of care, in light of the evolution of various factors: nutritional support, energy metabolism using indirect calorimetry, and markers of organ failure, will be analyzed.
This pilot study will lay the groundwork for those aiming to study other specific ICU populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to surgical intensive care | – | – |
| Patients admitted to neurosurgical intensive care for serious brain injury | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient admitted to neurosurgical or surgical intensive care for severe brain injury, traumatic or not, requiring intubation, eligible for indirect calorimetry measurements, and whose expected length of stay is > 48 hours and Any adult patient admitted to surgical intensive care for multiple trauma without associated brain injury and/or for shock (hemorrhagic or septic*) and whose expected length of stay is > 48 hours.
Key inclusion criteria (2 listed)
- Brain-injured patient group: Any adult patient admitted to neurosurgical or surgical intensive care for severe brain injury, traumatic or not, requiring intubation, eligible for indirect calorimetry measurements, and whose expected length of stay is > 48 hours.
- Control group: Any adult patient admitted to surgical intensive care for multiple trauma without associated brain injury and/or for shock (hemorrhagic or septic) and whose expected length of stay is > 48 hours.
Key exclusion criteria (7 listed)
- Refusal to participate in the study (request of non-opposition from relatives if the patient is unfit)
- Lack of social security affiliation;
- Minor patient;
- Patient under legal protection (guardianship or guardianship);
- Pregnant woman;
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
To describe the intestinal microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury based on analysis of admission stools by rectal swab.
Time frame: At Enrollment visit and Day 28
Analysis of the intestinal microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury using metagenomics (composition and diversity).
4 secondary outcomes
To compare the microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury with that of patients with multiple trauma and/or shock.
Time frame: At enrolment visit and Day 28
To analyze the changes in the intestinal microbiota of these patients as a function of nutritional interventions.
Time frame: Day 7
To analyze the changes in the intestinal microbiota of these patients as a function of anti-infectious therapies.
Time frame: Day 7
To analyze the links between these modifications and the evolution of organ failures during the first week of hospitalization.
Time frame: Day 7
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 10 Jul 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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.
Emilie EO OCCHIALI, Doctor study director
University Rouen 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 Intestinal Microbiota Between Different Groups, run by University Hospital, Rouen at 1 site in France.
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 2 inclusion and 7 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 10 Jul 2025. 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 France. 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 David DM MALLET, Director (02 32 88 82 65 ext. +33, David.Mallet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the intestinal microbiota of patients admitted to surgical or neurosurgical intensive care for severe brain injury based on analysis of admission stools by rectal swab. (time frame: At Enrollment visit and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.