Gut Dysbiosis in Spinal Cord Injury Rehabilitation

NCT06892106 | Completed

• 1 other identifier: 246/2019-2
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Spinal Cord Injury; Gut Dysbiosis; Immune Dysfunction

Keywords

Spinal Cord Injury; Rehabilitation; Gut Microbiota; Immune System; Gut-Immune-CNS Axis

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  From hospital admission until to one-year post-injury

Secondary Outcomes (3)

• Change in bowel function from hospital admission to 1-year post-injury

  From hospital admission until to one-year post-injury

• Change in immunological and inflammation biomarkers

  From hospital admission until to one-year post-injury

• Change in gut microbiota-produced metabolites

  From hospital admission until to one-year post-injury

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Academico Clínico Egas Moniz Health Alliance: lead
• Centro de Reabilitacao do Norte: collaborator
• Unidade Local de Saude de Gaia e Espinho EPE: collaborator
• Aveiro Institute of Biomedicine (iBiMED): collaborator
• Aveiro University: collaborator

Study Sites (1)

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, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal and blood samples

MeSH Terms

Conditions

Spinal Cord Injuries; Immune System Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria Ribeiro da Cunha, PhD

  Centro de Reabilitação do Norte (CRN) / Unidade Local de Saúde Gaia e Espinho (ULSGE))

  PRINCIPAL INVESTIGATOR

• Sandra Vieira

  Institute of Biomedicine - Aveiro University (iBiMED-UA)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: May 1, 2021
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

PT (1)