NCT02903472

Brief Summary

Changes in the GI microbiota and/or metabolomics have been linked to evolving transformations in immune system function and infection rates in experimental SCI in animal models. A recent study involving chronic survivors of SCI show distinct GI microbiome changes in comparison to healthy controls. GI microbial metabolism of dietary components has been causally linked to various health conditions, such as cardiovascular disease, infections, which is an ongoing concern for chronic SCI survivors. It is probable that alterations of GI microbiota are established acutely after SCI and could subsequently alter medical care and impact health outcomes for people living with SCI. This project is a pilot study to describe any changes in the GI and urinary tract microbiota as they appear over the first year after SCI. When available, data on factors, other than SCI, that may impact change in the gut microbiome after SCI will also be noted, including:

  • the level and severity of SCI,
  • the time since SCI,
  • the person's immune profile,
  • the antibiotic regimen of the individual and time since antibiotic administration,
  • the incidence and type of infections after SCI and
  • the person's diet or activities after SCI

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

September 13, 2016

Last Update Submit

February 2, 2021

Conditions

Spinal Cord Injury

Keywords

SCImicrobiomemetabolomeGIUTIDNAgenomicsinfectionstetraplegicparaplegic

Outcome Measures

Primary Outcomes (1)

  • Changes in GI microbiota

    Establishing the correlations between changes in neurological and functional capabilities in individuals with SCI and difference in the gut intestinal (GI) microbiota or metabolome and determining how such changes contribute to increased rates of infections

    one year

Study Arms (2)

Acute to first year after SCI

Individuals sustained SCI within a 1-year period

Chronic

Individuals sustained SCI more than1 year ago

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from both the acute and chronic populations of people living with SCI, specifically those treated as either inpatients and/or outpatients.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

University of Calgary Department of Clinical Neurosciences

Calgary, Alberta, Canada

Location

Stan Cassidy Center for Rehabilitation

Fredericton, New Brunswick, Canada

Location

Spinal Cord Injury Unit, Institut Guttmann Barcelona

Barcelona, Spain

Location

Balgrist University Hospital

Zurich, Switzerland

Location

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Çankaya, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool and urine samples

MeSH Terms

Conditions

Spinal Cord InjuriesInfections

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • John Steeves, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Matthias Walter, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Brett Finlay, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

September 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)CH(1)CA(2)ES(1)US(1)