Spinal Cord InjurySCIMBIONTNCT06892106
Gut Dysbiosis in Spinal Cord Injury Rehabilitation
An observational study of Spinal Cord Injury and Gut Dysbiosis, run by Centro Academico Clínico Egas Moniz Health Alliance at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Gut Dysbiosis, Immune Dysfunction
- How many people
- 106 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2021to 16 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde de Gaia e Espinho (ULSGE), between 1st of May 2021 and 16th of October 2023, following a traumatic spinal cord injury.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde Gaia e Espinho (ULSGE)
Vila Nova de Gaia, Porto District, 4405 - 565 Vila Nova de Gaia
About this study
Official title: Spinal Cord Injury Rehabilitation: Gut Dysbiosis and Immune Biomarkers As Functional Prognosis Tools and New Therapeutic Targets - a Longitudinal Prospective Cohort Study
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?
Read the detailed description
Background:
Spinal cord injury (SCI) is a devastating condition with no effective cure. Gut dysbiosis and chronic immune dysfunction are common complications that may hinder recovery. This study aims to investigate the role of gut microbiota and related immune biomarkers and metabolites in the functional recovery of SCI patients during the subacute phase. This study hypothesizes that alterations in the gut microbiota and associated immune responses are critical factors influencing recovery trajectories in patients during the subacute phase of SCI.
Therefore, we aim to investigate the intricate relationship between gut microbiota composition, immune biomarkers, and functional outcomes in this population, to develop a probiotic-based therapeutic intervention.
Study Objectives:
- To characterize gut microbiota changes in subacute SCI patients;
- To identify microbiota-based biomarkers for prognosis;
- To correlate gut dysbiosis with systemic inflammation and functional recovery.
Exploratory objective:
- To assess the potential of probiotic-based approaches for therapeutic intervention.
Study Design and Methodology:
This is an observational, longitudinal, prospective cohort study involving 66 patients with subacute SCI (28 patients with A and B classification in ASIA Impairment Scale - AIS and 38 patients with C and D classification in AIS) and 40 able-bodied control participants.
Participant Recruitment and Enrollment:
Participants admitted for hospitalization at Centro de Reabilitação do Norte (CRN)/Unidade Local de Saúde de Gaia e Espinho (ULSGE) were recruited. Inclusion and exclusion criteria were clearly defined to ensure a homogenous study population.
Data Collection:
Clinical data, including neurological assessments, functional outcome measures (e.g., ASIA Impairment Scale, Functional Independence Measure), and demographic information, were collected at three time points:
T1: Admission to the rehabilitation unit (subacute phase). T2: Discharge from the rehabilitation unit. T3: One-year post-injury follow-up. Biological samples, including fecal samples and blood samples, were collected at each time point (T1, T2, and T3).
Laboratory Analyses:
Microbiome Analysis: Fecal samples undergone 16S rRNA gene sequencing to determine gut microbiota composition and diversity.
Immune Biomarker Quantification: Blood samples were analyzed to quantify levels of key inflammatory cytokines, chemokines, and other immune markers.
Metabolite Profiling: Fecal samples, and/or blood samples will be analyzed using metabolomics techniques to identify gut-derived metabolites that may influence recovery.
Statistical Analysis:
Descriptive statistics (means) were calculated for all outcome measures. Data association studies included gut microbiota composition, AIS-based rehabilitation outcomes (percentage improvement), comorbidities (e.g., UTIs), immune biomarkers, and metabolites at T1-T3, with focus on microbiota linked to SCI. Potential confounders (age, gender, injury level, etc.) and biases were accounted for.
Independent group comparisons (e.g., T1 cytokine levels) used t-tests or Mann-Whitney U-tests, while dependent group comparisons (e.g., cytokine changes within AIS groups) used paired t-tests or Wilcoxon tests. ANOVA, multivariate analyses, and generalized linear models (regression, mixed-model repeated measures) assessed inter-group data and associations between gut microbiota changes and functional/immunological outcomes.
- Conditions
- Spinal Cord Injury, Gut Dysbiosis, Immune Dysfunction
- Keywords
- Spinal Cord Injury, Rehabilitation, Gut Microbiota, Immune System, Gut-Immune-CNS Axis
- Medical subject headings
- Spinal Cord Injuries, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injury patients - A or B AIS classification | Spinal cord injury patients admitted for hospitalization at Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. with A (complete) or B (sensory incomplete) classification in The American Spinal Injury Association (ASIA) Impairment Scale (AIS) | |
| Spinal cord injury patients - C or D AIS classification | Spinal cord injury patients admitted for hospitalization at Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. with C or D (motor incomplete) classification in The American Spinal Injury Association (ASIA) Impairment Scale (AIS) | |
| Able-bodied controls | Age, gender and body mass index matched control group of participants recruited among able-bodied personnel from Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. or their relatives, without any known CNS disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal microbiota
Microbiota relative abundance of different taxonomic levels to estimate change in alpha-diversity (diversity within different samples from the same individual) and in beta-diversity (diversity between groups) from hospital admission to 1-year post-injury
Measured: From hospital admission until to one-year post-injury
Change in functional independence from hospital admission to 1-year post-injury
Change in functional independence, as measured by the Spinal Cord Independence Measure, 4th version (SCIM IV) and by Functional Independence Measure (FIM), from hospital admission to 1-year post-injury.
Measured: From hospital admission until to one-year post-injury
Change in neuromotor impairment from hospital admission to 1-year post-injury
Change in the total ASIA Impairment Scale (AIS) motor score from hospital admission to 1-year post-injury.
Measured: From hospital admission until to one-year post-injury
Secondary outcomes (3)
Change in bowel function from hospital admission to 1-year post-injury
Change in bowel function, as measured by the Neurogenic Bowel Dysfunction (NBD) Score, from hospital admission to 1-year post-injury.
Measured: From hospital admission until to one-year post-injury
Change in immunological and inflammation biomarkers
Change in immunologic and inflammatory serum biomarkers (interleukins, cytokines), measured via ELISA techniques -TNF-alfa, IL-1beta, IL-6, IL-8 and IL-10, IL-1alfa and cytokine MIP2 - from hospital admission to 1-year post-injury.
Measured: From hospital admission until to one-year post-injury
Change in gut microbiota-produced metabolites
Change in gut microbiota-produced metabolites, measured by Nuclear Magnetic Resonance (NMR) and Liquid Chromatography-Mass Spectrometry (LC-MS/MS), from hospital admission to 1-year post-injury
Measured: From hospital admission until to one-year post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 May 2021
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Academico Clínico Egas Moniz Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Reabilitacao do Norte, Unidade Local de Saude de Gaia e Espinho EPE, Aveiro Institute of Biomedicine (iBiMED), Aveiro University
- Responsible party
- Sponsor
- Investigators
- Maria Ribeiro da Cunha, PhD, Principal investigator, Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde Gaia e Espinho (ULSGE))Sandra Vieira, Study director, Institute of Biomedicine - Aveiro University (iBiMED-UA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892106
- Sponsor's protocol ID
- 246/2019-2
- Acronym
- SCIMBIONT
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Rehabilitation: Gut Dysbiosis and Immune Biomarkers As Functional Prognosis Tools and New Therapeutic Targets - a Longitudinal Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06892106
- Acronym / sponsor ID
- SCIMBIONT / 246/2019-2
- Conditions
- Spinal Cord Injury, Gut Dysbiosis, Immune Dysfunction
- Keywords
- Spinal Cord Injury, Rehabilitation, Gut Microbiota, Immune System, Gut-Immune-CNS Axis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centro Academico Clínico Egas Moniz Health AllianceUniversity, hospital or other
- Collaborators
- Centro de Reabilitacao do Norte, Unidade Local de Saude de Gaia e Espinho EPE, Aveiro Institute of Biomedicine (iBiMED), Aveiro University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Background:
Spinal cord injury (SCI) is a devastating condition with no effective cure. Gut dysbiosis and chronic immune dysfunction are common complications that may hinder recovery. This study aims to investigate the role of gut microbiota and related immune biomarkers and metabolites in the functional recovery of SCI patients during the subacute phase. This study hypothesizes that alterations in the gut microbiota and associated immune responses are critical factors influencing recovery trajectories in patients during the subacute phase of SCI.
Therefore, we aim to investigate the intricate relationship between gut microbiota composition, immune biomarkers, and functional outcomes in this population, to develop a probiotic-based therapeutic intervention.
Study Objectives:
- To characterize gut microbiota changes in subacute SCI patients;
- To identify microbiota-based biomarkers for prognosis;
- To correlate gut dysbiosis with systemic inflammation and functional recovery.
Exploratory objective:
- To assess the potential of probiotic-based approaches for therapeutic intervention.
Study Design and Methodology:
This is an observational, longitudinal, prospective cohort study involving 66 patients with subacute SCI (28 patients with A and B classification in ASIA Impairment Scale - AIS and 38 patients with C and D classification in AIS) and 40 able-bodied control participants.
Participant Recruitment and Enrollment:
Participants admitted for hospitalization at Centro de Reabilitação do Norte (CRN)/Unidade Local de Saúde de Gaia e Espinho (ULSGE) were recruited. Inclusion and exclusion criteria were clearly defined to ensure a homogenous study population.
Data Collection:
Clinical data, including neurological assessments, functional outcome measures (e.g., ASIA Impairment Scale, Functional Independence Measure), and demographic information, were collected at three time points:
T1: Admission to the rehabilitation unit (subacute phase). T2: Discharge from the rehabilitation unit. T3: One-year post-injury follow-up. Biological samples, including fecal samples and blood samples, were collected at each time point (T1, T2, and T3).
Laboratory Analyses:
Microbiome Analysis: Fecal samples undergone 16S rRNA gene sequencing to determine gut microbiota composition and diversity.
Immune Biomarker Quantification: Blood samples were analyzed to quantify levels of key inflammatory cytokines, chemokines, and other immune markers.
Metabolite Profiling: Fecal samples, and/or blood samples will be analyzed using metabolomics techniques to identify gut-derived metabolites that may influence recovery.
Statistical Analysis:
Descriptive statistics (means) were calculated for all outcome measures. Data association studies included gut microbiota composition, AIS-based rehabilitation outcomes (percentage improvement), comorbidities (e.g., UTIs), immune biomarkers, and metabolites at T1-T3, with focus on microbiota linked to SCI. Potential confounders (age, gender, injury level, etc.) and biases were accounted for.
Independent group comparisons (e.g., T1 cytokine levels) used t-tests or Mann-Whitney U-tests, while dependent group comparisons (e.g., cytokine changes within AIS groups) used paired t-tests or Wilcoxon tests. ANOVA, multivariate analyses, and generalized linear models (regression, mixed-model repeated measures) assessed inter-group data and associations between gut microbiota changes and functional/immunological outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injury patients - A or B AIS classification | – | –Spinal cord injury patients admitted for hospitalization at Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. with A (complete) or B (sensory incomplete) classification in The American Spinal Injury Association (ASIA) Impairment Scale (AIS) |
| Spinal cord injury patients - C or D AIS classification | – | –Spinal cord injury patients admitted for hospitalization at Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. with C or D (motor incomplete) classification in The American Spinal Injury Association (ASIA) Impairment Scale (AIS) |
| Able-bodied controls | – | –Age, gender and body mass index matched control group of participants recruited among able-bodied personnel from Centro de Reabilitação do Norte, Unidade Local de Saúde de Gaia / Espinho, E.P.E. or their relatives, without any known CNS disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde de Gaia e Espinho (ULSGE), between 1st of May 2021 and 16th of October 2023, following a traumatic spinal cord injury.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in intestinal microbiota
Time frame: From hospital admission until to one-year post-injury
Microbiota relative abundance of different taxonomic levels to estimate change in alpha-diversity (diversity within different samples from the same individual) and in beta-diversity (diversity between groups) from hospital admission to 1-year post-injury
Change in functional independence from hospital admission to 1-year post-injury
Time frame: From hospital admission until to one-year post-injury
Change in functional independence, as measured by the Spinal Cord Independence Measure, 4th version (SCIM IV) and by Functional Independence Measure (FIM), from hospital admission to 1-year post-injury.
Change in neuromotor impairment from hospital admission to 1-year post-injury
Time frame: From hospital admission until to one-year post-injury
Change in the total ASIA Impairment Scale (AIS) motor score from hospital admission to 1-year post-injury.
3 secondary outcomes
Change in bowel function from hospital admission to 1-year post-injury
Time frame: From hospital admission until to one-year post-injury
Change in immunological and inflammation biomarkers
Time frame: From hospital admission until to one-year post-injury
Change in gut microbiota-produced metabolites
Time frame: From hospital admission until to one-year post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Ribeiro da Cunha, PhD principal investigator
Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde Gaia e Espinho (ULSGE))
Sandra Vieira study director
Institute of Biomedicine - Aveiro University (iBiMED-UA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Gut Dysbiosis, run by Centro Academico Clínico Egas Moniz Health Alliance at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal microbiota (time frame: From hospital admission until to one-year post-injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.