Gastrointestinal and Urinary Tract Microbiome After SCI

INCLUSION CRITERIA ------------------------------------

• Participants with acute SCI

  • Male or Female of the age of majority in his or her province/state/country OR Minor between 16 y.o. and the age of majority with informed consent provided by participant and parent or guardian.
  • Tetraplegic or paraplegic motor complete SCI (AIS A, B) or motor incomplete SCI (AIS C, D) involving a single non-penetrating traumatic injury to the C2-S1 spinal cord, treated surgically or non-surgically.
  • Preferably participants will be admitted to a study center within 48 hours of SCI. However, participants can be included within 7 days post injury.
  • Able to provide informed consent.
  • Able to converse in the language native to the country where the hospital is located.
  • Have the capacity to follow the study procedure.

• Participants with chronic SCI

  • Male or Female of the age of majority in his or her province/state/country OR Minor between 16 y.o. and the age of majority with informed consent provided by participant and parent or guardian
  • Tetraplegic or paraplegic motor complete SCI (AIS A, B) or motor incomplete SCI (AIS C, D) involving a single non-penetrating traumatic injury to the C2-S1 spinal cord, treated surgically or non-surgically
  • Able to provide informed consent
  • Able to converse in the language native to the country where the hospital is located
  • Have the capacity to follow the study procedure

EXCLUSION CRITERIA ------------------------------------

• Participants with acute SCI

  • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
  • Penetrating spinal cord injury (including gunshot wounds)
  • Associated head injury or other major cognitive deficit (i.e. condition where comprehension may be impaired such that informed consent process or outcome assessment cannot be completed with confidence)
  • Concomitant medical conditions associated with SCI that would interfere with informed consent process or outcome assessment
  • Pre-existing history of a chronic bowel disorder (e.g. Crohn's disease, ulcerative colitis)

  • Pre-existing history of:

    • recurrent infectious diseases (3 or more times a year), e.g. urinary tract infections, pneumonia
    • Immune disorders (e.g. rheumatoid arthritis, systemic lupus) or
    • neurodegenerative syndromes
  • Presence of a systemic disease that might interfere with the safety, compliance or assessments being used in this project (e.g., clinically significant cardiac disease, including chronic hypertension, HIV)
  • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to participate in the study
  • Female participants who are pregnant

• Participants with chronic SCI

  • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
  • Penetrating spinal cord injury (including gunshot wounds)
  • Associated head injury or other major cognitive deficit (i.e. condition where comprehension may be impaired such that informed consent process or outcome assessment cannot be completed with confidence)
  • Concomitant medical conditions associated with SCI that would interfere with informed consent process or outcome assessment
  • Pre-existing history of a chronic bowel disorder (e.g. Crohn's disease, ulcerative colitis)
  • Presence of a systemic disease that might interfere with the safety, compliance or assessments being used in this project (e.g., clinically significant cardiac disease, including chronic hypertension, HIV)
  • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to participate in the study
  • Female participants who are pregnant