Intestinal microbiota in adults with severe brain injury

Study of the Intestinal Microbiota of Patients Admitted to Intensive Care for Severe Brain Injury.

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
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (other)
• Locations: 1 site (Rouen)
• Trial ID: NCT07058961 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rouen

• Services de Réanimation Chirurgicale Et Réanimation Neurochirurgicale — Rouen, France (RECRUITING)

Study contacts

• Study coordinator: David DM MALLET, Director

Conditions: Intestinal Microbiota Between Different Groups, brain-damaged patients