Spinal Cord InjuryNCT03319225
Examining the Distal Gut Microbiome After Spinal Cord Injury
An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the causes of gastrointestinal dysfunction after spinal cord injury. It has been thought that the microbiome (the community of bacteria in the body) may be one such cause. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 9 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with a spinal cord injury; Neurologically-intact controls
Who may be able to join
- Age 18-65
- ≥ 1 year post-injury
- Spinal cord injury resulting in Tetraplegia or Paraplegia (C5-T6) and motor complete or incomplete (AIS A-C) impairment. Injury level and impairment will be confirmed by an American Spinal Injury Association (ASIA) exam conducted less than 2 years before study entry. If longer than 2 years, a certified rater will repeat the exam.
- Self -reported history of constipation or other gastrointestinal dysfunction (e.g., extended bowel care time or difficulty in bowel emptying)
- Willingness to participate in the study
- Age 18 or over
- Willingness to participate in the study
Who cannot join
- Currently hospitalized
- American Spinal Injury Association (AIS) D-E
- Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
- Gastrointestinal surgery ≤ 3 months prior to study
- Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump
- Concurrent use of surface functional electrical stimulation (FES)
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- Neurologically-Intact Persons:
- Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
- Gastrointestinal surgery ≤ 3 months prior to study
- Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury
The purpose of this research study is to learn more about the causes of gastrointestinal dysfunction after spinal cord injury. It has been thought that the microbiome (the community of bacteria in the body) may be one such cause. The study will examine whether changes in the distal gut microbiome are related to gastrointestinal dysfunction in persons with Spinal Cord Injury and Non-Disabled Controls.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
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 |
|---|---|---|
| Tetraplegia | Persons with Tetraplegia | |
| Paraplegia | Persons with Paraplegia | |
| Neurologically-intact | Neurologically-intact controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize microbiome composition
Characterize the distal gut microbiome within and across the three groups
Measured: Study day 7
Secondary outcomes (3)
Gastrointestinal transit time
Measured by "Smart Pill" wireless motility capsule during gastric emptying
Measured: Study day 5
Autonomic state
Autonomic tone will be assessed indirectly using heart rate variability by measuring the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)
Measured: Baseline
Inflammatory state
Measured by protein levels of inflammatory biomarkers in plasma
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Dec 2017
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
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 MiamiThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark S. Nash, Ph.D., FACSM, University of Miami
- Investigators
- Mark S Nash, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319225
- Sponsor's protocol ID
- 20170526
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03319225
- Acronym / sponsor ID
- 20170526
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 24 Oct 2017 (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 purpose of this research study is to learn more about the causes of gastrointestinal dysfunction after spinal cord injury. It has been thought that the microbiome (the community of bacteria in the body) may be one such cause. The study will examine whether changes in the distal gut microbiome are related to gastrointestinal dysfunction in persons with Spinal Cord Injury and Non-Disabled Controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetraplegia | – | –Persons with Tetraplegia |
| Paraplegia | – | –Persons with Paraplegia |
| Neurologically-intact | – | –Neurologically-intact controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with a spinal cord injury; Neurologically-intact controls
Key inclusion criteria (7 listed)
- Age 18-65
- ≥ 1 year post-injury
- Spinal cord injury resulting in Tetraplegia or Paraplegia (C5-T6) and motor complete or incomplete (AIS A-C) impairment. Injury level and impairment will be confirmed by an American Spinal Injury Association (ASIA) exam conducted less than 2 years before study entry. If longer than 2 years, a certified rater will repeat the exam.
- Self -reported history of constipation or other gastrointestinal dysfunction (e.g., extended bowel care time or difficulty in bowel emptying)
- Willingness to participate in the study
Key exclusion criteria (10 listed)
- Currently hospitalized
- American Spinal Injury Association (AIS) D-E
- Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
- Gastrointestinal surgery ≤ 3 months prior to study
- Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump
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
Characterize microbiome composition
Time frame: Study day 7
Characterize the distal gut microbiome within and across the three groups
3 secondary outcomes
Gastrointestinal transit time
Time frame: Study day 5
Autonomic state
Time frame: Baseline
Inflammatory state
Time frame: Baseline
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 9 Oct 2018.
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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.
Mark S Nash, Ph.D. principal investigator
University of Miami
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, run by University of Miami at 1 site in United States.
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 7 inclusion and 10 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 9 Oct 2018. 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 United States. 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?
Characterize microbiome composition (time frame: Study day 7). 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 9 Oct 2018.