Long-term Recovery and Microbiota-Gut-Brain Axis Disruption After Traumatic Brain Injury

Not yet recruitingOBSERVATIONAL
Enrollment

160

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Traumatic Brain Injury
Interventions
DIAGNOSTIC_TEST

blood-based protein biomarker assessments

Assessment of multiple blood-based biomarkers of different cellular origin and inflammatory mediators

DIAGNOSTIC_TEST

blood-based metabolomic/lipidomic biomarker assessments

Assessment of multiple blood-based TBI-related metabolomic and lipidomic biomarkers

DIAGNOSTIC_TEST

Diffusion-weighted magnetic resonance imaging (brain)

Diffusion-weighted magnetic resonance imaging

DIAGNOSTIC_TEST

Structural magnetic resonance imaging (brain)

Structural magnetic resonance imaging

DIAGNOSTIC_TEST

PET imaging (brain)

Positron emission tomography imaging

PROCEDURE

Standard colonoscopy with pinch biopsies

Standard colonoscopy including pinch biopsies from the bowel wall at several levels (terminal ileum, ascending colon, transverse colon, descending colon, and rectosigmoideum) for histology, microbiome analysis and metabolomics

DIAGNOSTIC_TEST

Fecal microbiome assessments

Fecal microbiome assessments (DNA)

All Listed Sponsors
collaborator

Aalto University

OTHER

collaborator

University of Geneva, Switzerland

OTHER

collaborator

Göteborg University

OTHER

collaborator

University of Cambridge

OTHER

collaborator

Örebro University, Sweden

OTHER

collaborator

University of Turku

OTHER

lead

Turku University Hospital

OTHER_GOV

NCT06927063 - Long-term Recovery and Microbiota-Gut-Brain Axis Disruption After Traumatic Brain Injury | Biotech Hunter | Biotech Hunter