Status:
NOT_YET_RECRUITING
Long-term Recovery and Microbiota-Gut-Brain Axis Disruption After Traumatic Brain Injury
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Aalto University
University of Geneva, Switzerland
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
Brief Summary
The OVERCOME-TBI project aims to collect multimodal data approximately 1-4 and 11-14 years after an earlier well-documented traumatic brain injury (TBI) and examine factors that influence disease prog...
Detailed Description
This detailed description outlines the scientific background, registry procedures and quality control strategies for the OVERCOME-TBI study. The study builds on previous research cohorts Evidence-base...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All those who are alive and give their consent will be included from our previous prospective studies (TBIcare or PACoS-TBI)
- Exclusion Criteria (neurological and imaging studies):
- For patients with TBI there are no exclusion criteria, and all eligible patients who give consent will be recruited
- Those patients and controls with contraindication for head MRI (MRI-incompatible heart pacemaker, weight over 200 kg, mechanical heart valve prosthesis, first trimester of pregnancy, orbital area tattoo) will not undergo head MRI. Instead, they we will undergo the other assessments
- For controls, those who have suffered a TBI or any other brain disorder after the TBIcare or PACoS-TBI study will be excluded.
- Exclusion Criteria (colonoscopy)
- Diagnosis of IBD or other diagnosis besides IBS causing severe GI symptoms, such as microscopic colitis or bile acid diarrhea
- Poorly controlled celiac disease
- Colorectal cancer diagnosed within five years
- Antibiotic or probiotic treatment, on-going or previous month.
- Unwilling or unable to undergo colonoscopy and/or standard bowel preparation.
- Significantly increased risk of heart or kidney failure or electrolyte imbalances due to bowel preparation (frailty, serious pre-existing heart or kidney insufficiency).
- Altered bowel anatomy after significant operation. Appendicectomy or cholecystectomy are considered minor operations.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06927063
Start Date
May 1 2025
End Date
December 31 2028
Last Update
April 15 2025
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