Spinal Cord InjuryNCT02903472
Gastrointestinal and Urinary Tract Microbiome After SCI
An observational study of Spinal Cord Injury, run by University of British Columbia at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 43 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Sep 2017to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Canada2 sites
University of Calgary Department of Clinical Neurosciences
Calgary, Alberta
Stan Cassidy Center for Rehabilitation
Fredericton, New Brunswick
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Turkey (Türkiye)1 site
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya, 06100
About this study
Official title: Gastrointestinal (GI) and Urinary Tract (UT) Microbiome (MICRO) After Spinal Cord Injury (SCI)
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
Read the detailed description
Study 1 - Acute to first year after SCI:
The investigators wish to recruit 4 types of SCI participants (~8 tetraplegic motor complete SCI participants, ~8 tetraplegic motor incomplete SCI, ~8 paraplegic motor complete SCI and ~8 paraplegic motor incomplete SCI). This totals 32 participants.
The investigators will non-invasively collect small (<1 gram) stool and urine (<1 ml) samples from people who have suffered an acute SCI and have been admitted to their hospital for care and treatment of their injury.
The investigators will track changes in the microbiota, microbiome and metabolome within the gastrointestinal (GI) tract of people after acute spinal cord injury (SCI) through the non-invasive collection of a small stool sample during normal bowel routines at baseline (within the first week after SCI). Subsequent samples would be obtained in the same non-invasive nature at approximately 1, 3, 6, and 12 months after SCI, as part of any daily (in-patient or at home, outpatient) bowel routine. The stool samples will be processed for genomic analysis to identify GI bacterial species and any changes in an individual's GI microbiota and/or dysbiosis during the first year after SCI. As SCI increases the incidence and prevalence of urinary tract infections (UTIs), the investigators will track alteration within the microbiota of the urinary tract to ascertain whether there are links in the bacterial taxa between the GI system and urinary tract.
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Study 2 - Chronic:
This study will attempt to recruit ~ 20 chronic SCI participants with or without recurrent infections (e.g. UTI, skin or systemic) to ascertain whether there is a correlation between a dysbiotic microbiota presentation and recurrent infections.
A small stool or urine sample will be obtained at home by participants and subsequently collected for genomic analysis during a person's routine outpatient clinic visit.
All replicate data (3 samples per individual at 3 different time points - 1, 6 and 12 months post baseline visit) from chronic participants would be matched as much as possible for age, gender, diet, type of SCI, time since SCI, activity, and should only differ in terms of recurrent infections and antibiotic prescriptions. The goal here would be to characterize any gut microbiota differences between the two disparate groups. The data may guide the development of future studies to investigate treatment options. During chronic SCI, many recurrent infections are UTIs; thus, the investigators will also monitor differences between the two group in the microbiota and metabolomics of the urinary tract.
- Conditions
- Spinal Cord Injury
- Keywords
- SCI, microbiome, metabolome, GI, UTI, DNA, genomics, infections, tetraplegic, paraplegic
- Medical subject headings
- Spinal Cord Injuries, Infections
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 |
|---|---|---|
| Acute to first year after SCI | Individuals sustained SCI within a 1-year period | |
| Chronic | Individuals sustained SCI more than1 year ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 Sep 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Responsible party
- Principal investigator, Matthias Walter, University of British Columbia
- Investigators
- John Steeves, PhD, Principal investigator, University of British ColumbiaMatthias Walter, MD, PhD, Principal investigator, University of British ColumbiaBrett Finlay, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903472
- Sponsor's protocol ID
- H16-00954
- Status last verified
- Feb 2021
- First submitted
- 13 Sep 2016
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal (GI) and Urinary Tract (UT) Microbiome (MICRO) After Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT02903472
- Acronym / sponsor ID
- H16-00954
- Conditions
- Spinal Cord Injury
- Keywords
- SCI, microbiome, metabolome, GI, UTI, DNA, genomics, infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
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
Detailed description
Study 1 - Acute to first year after SCI:
The investigators wish to recruit 4 types of SCI participants (~8 tetraplegic motor complete SCI participants, ~8 tetraplegic motor incomplete SCI, ~8 paraplegic motor complete SCI and ~8 paraplegic motor incomplete SCI). This totals 32 participants.
The investigators will non-invasively collect small (<1 gram) stool and urine (<1 ml) samples from people who have suffered an acute SCI and have been admitted to their hospital for care and treatment of their injury.
The investigators will track changes in the microbiota, microbiome and metabolome within the gastrointestinal (GI) tract of people after acute spinal cord injury (SCI) through the non-invasive collection of a small stool sample during normal bowel routines at baseline (within the first week after SCI). Subsequent samples would be obtained in the same non-invasive nature at approximately 1, 3, 6, and 12 months after SCI, as part of any daily (in-patient or at home, outpatient) bowel routine. The stool samples will be processed for genomic analysis to identify GI bacterial species and any changes in an individual's GI microbiota and/or dysbiosis during the first year after SCI. As SCI increases the incidence and prevalence of urinary tract infections (UTIs), the investigators will track alteration within the microbiota of the urinary tract to ascertain whether there are links in the bacterial taxa between the GI system and urinary tract.
------------------------------------------------------------------------------
Study 2 - Chronic:
This study will attempt to recruit ~ 20 chronic SCI participants with or without recurrent infections (e.g. UTI, skin or systemic) to ascertain whether there is a correlation between a dysbiotic microbiota presentation and recurrent infections.
A small stool or urine sample will be obtained at home by participants and subsequently collected for genomic analysis during a person's routine outpatient clinic visit.
All replicate data (3 samples per individual at 3 different time points - 1, 6 and 12 months post baseline visit) from chronic participants would be matched as much as possible for age, gender, diet, type of SCI, time since SCI, activity, and should only differ in terms of recurrent infections and antibiotic prescriptions. The goal here would be to characterize any gut microbiota differences between the two disparate groups. The data may guide the development of future studies to investigate treatment options. During chronic SCI, many recurrent infections are UTIs; thus, the investigators will also monitor differences between the two group in the microbiota and metabolomics of the urinary tract.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute to first year after SCI | – | –Individuals sustained SCI within a 1-year period |
| Chronic | – | –Individuals sustained SCI more than1 year ago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Participants with acute SCI
- Participants with chronic SCI
Key exclusion criteria (22 listed)
- Participants with acute SCI
- Participants with chronic SCI
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
Changes in GI microbiota
Time frame: one year
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
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 5 Feb 2021.
- Individual participant dataSharing planned: No
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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.
John Steeves, PhD principal investigator
University of British Columbia
Matthias Walter, MD, PhD principal investigator
University of British Columbia
Brett Finlay, PhD principal investigator
University of British Columbia
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of British Columbia at 6 sites in 5 countries.
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 13 inclusion and 22 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, United States, Spain, Switzerland, Turkey (Türkiye). 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?
Changes in GI microbiota (time frame: one year). 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 5 Feb 2021.