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Research summary · AI summary · not yet reviewedHuman studyObservationalPeer-reviewed
Human Traumatic Brain Injury (TBI) and Microbiome Study
The OVERCOME-TBI study will examine up to 160 patients with TBI and 30 orthopaedic controls over 2-15 years. Researchers aim to identify biomarkers and gut microbiome profiles related to recovery and neurodegeneration using imaging and biological sampling techniques.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the links between neuroinflammation, gut microbiota, and recovery can pave the way for better diagnostics and targeted interventions for TBI patients.
What this does not prove
This observational study does not prove a causal relationship between gut microbiota and recovery following TBI.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 160 · up to 160 patients with TBI and 30 orthopaedic injury controls
- Randomised
- Not reported
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- 2026-09-23
- Evidence reviewed
- Abstract only
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
- Primary evidenceLong-term recovery and microbiota-gut-brain axis disruption after traumatic brain injury (OVERCOME-TBI): protocol for a prospective, observational clinical study. ↗DOI: 10.1136/bmjopen-2026-120552
Supporting passages (14)
study designMETHODS AND ANALYSIS: This is a prospective, observational study with long-term follow-up of two previously established TBI cohorts-the Evidence-based Diagnostic and Treatment Planning Solution for Traumatic Brain Injuries (TBIcare; recruited 2011-2013) and the Pathophysiological Characterisation of Severe TBI (PACoS-TBI; recruited 2020-2023).
subjectsParticipants are re-contacted and re-consented for these chronic-phase assessments.
sample sizeUp to 160 patients with TBI and 30 orthopaedic injury controls will undergo multimodal examinations: neurological and neuropsychological testing, advanced MRI including multishell diffusion and resting-state functional MRI, positron emission tomography (PET) with the radioligand [11C]PK11195, blood-based proteomics, lipidomics, metabolomics, faecal and intestinal microbiome profiling and colonoscopy biopsies.
sample size basisUp to 160 patients with TBI and 30 orthopaedic injury controls will undergo multimodal examinations: neurological and neuropsychological testing, advanced MRI including multishell diffusion and resting-state functional MRI, positron emission tomography (PET) with the radioligand [11C]PK11195, blood-based proteomics, lipidomics, metabolomics, faecal and intestinal microbiome profiling and colonoscopy biopsies.
controlledUp to 160 patients with TBI and 30 orthopaedic injury controls will undergo multimodal examinations: neurological and neuropsychological testing, advanced MRI including multishell diffusion and resting-state functional MRI, positron emission tomography (PET) with the radioligand [11C]PK11195, blood-based proteomics, lipidomics, metabolomics, faecal and intestinal microbiome profiling and colonoscopy biopsies.
peer reviewedThe results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement, with the aim of developing personalised diagnostics and novel therapeutic targets to alleviate the chronic consequences of TBI.
regulatory approvalETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethical Committee of the Wellbeing Services County of Southwest Finland.
regulatory approval detailsEthical approval has been obtained from the Ethical Committee of the Wellbeing Services County of Southwest Finland.
publication datePublication date: 2026-09-23
comparatorUp to 160 patients with TBI and 30 orthopaedic injury controls will undergo multimodal examinations: neurological and neuropsychological testing, advanced MRI including multishell diffusion and resting-state functional MRI, positron emission tomography (PET) with the radioligand [11C]PK11195, blood-based proteomics, lipidomics, metabolomics, faecal and intestinal microbiome profiling and colonoscopy biopsies.
primary endpointPrimary outcomes include neuroinflammatory burden (biochemical and PET), longitudinal functional outcomes (Glasgow Outcome Scale Extended) and gut microbiota composition.
follow upat chronic time points (2-5 and 12-15 years post-injury).
findingsThe OVERCOME-TBI study investigates the long-term functional, cognitive, imaging, biochemical and gastrointestinal outcomes after TBI of all severities, with the aim of identifying biomarkers and microbiome signatures associated with progressive neurodegeneration and poor recovery.
limitationsTitle: Long-term recovery and microbiota-gut-brain axis disruption after traumatic brain injury (OVERCOME-TBI): protocol for a prospective, observational clinical study.
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