Gut Dysbiosis in Spinal Cord Injury Rehabilitation (NCT06892106) | Clinical Trial Compass
CompletedNot Applicable
Gut Dysbiosis in Spinal Cord Injury Rehabilitation
Portugal106 participantsStarted 2021-05-01
Plain-language summary
The goal of this study is to investigate the role of gut microbiota, and related immune biomarkers and metabolites, in the functional recovery of spinal cord injury patients during the subacute phase. The main question it aims to answer is:
How does gut microbiota dysbiosis impact functional recovery in subacute SCI patients, in a way that future targeted probiotic interventions may improve SCI outcomes?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (≥18 years) with traumatic spinal cord injury.
* Injury occurred less than 6 months ago (subacute phase).
* Any neurological level of injury (AIS A-D).
Exclusion Criteria:
* Use of probiotics or immunomodulatory drugs in the last month.
* Major gastrointestinal surgery in the last 5 years.
* Active gastrointestinal diseases or other CNS diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in intestinal microbiota
Timeframe: From hospital admission until to one-year post-injury
2
Change in functional independence from hospital admission to 1-year post-injury
Timeframe: From hospital admission until to one-year post-injury
3
Change in neuromotor impairment from hospital admission to 1-year post-injury
Timeframe: From hospital admission until to one-year post-injury
Trial details
NCT IDNCT06892106
SponsorCentro Academico Clínico Egas Moniz Health Alliance