Intestinal microbiota in adults with severe brain injury
Official title: Study of the Intestinal Microbiota of Patients Admitted to Intensive Care for Severe Brain Injury.
Run by University Hospital, Rouen · NCT07058961 · Data updated 2026-11-12
We will test whether the gut microbiota of adults with severe brain injury who are intubated differs from that of other critically ill surgical patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | November 28, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07058961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults admitted to neurosurgical or surgical intensive care with severe brain injury who are intubated and expected to stay more than 48 hours.
✕Probably not a fit
Minors, pregnant women, patients under legal protection, moribund patients or those expected to stay 48 hours or less, and patients who are not critically ill are unlikely to receive direct benefit.
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 maps the intestinal microbiota of adults admitted to neurosurgical or surgical intensive care for severe brain injury using rectal swabs at admission and high-throughput sequencing plus metabolomic analysis. A control group of adults admitted for multiple trauma or shock without brain injury will be sampled for comparison. Clinical factors such as antibiotic exposure, gastric acid suppression, route of nutrition, and sedation will be recorded to explore influences on microbiota composition. The aim is to identify consistent microbiota patterns in this homogeneous patient group that could inform targeted restorative therapies.
Why it matters
Potential benefit: If patterns are identified, the findings could guide targeted therapies to restore gut microbiota and possibly improve outcomes for brain-injured ICU patients.
How similar studies have gone: Previous studies in mixed ICU populations have been conflicting and inconclusive, so applying sequencing and metabolomics to a homogeneous brain-injured group is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * 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.);
Where it's running
-
Services de Réanimation Chirurgicale Et Réanimation Neurochirurgicale
Rouen, France Recruiting
Study contacts
- Study coordinator: David DM MALLET, Director
- Email: David.Mallet@chu-rouen.fr
- Phone: 02 32 88 82 65
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.