Examining the Distal Gut Microbiome After Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury

Conditions
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Spinal Cord Injury

Participation Criteria
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Eligibility Criteria
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Persons with a Spinal Cord Injury: Inclusion Criteria: 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 Exclusion Criteria: 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) Neurologically-Intact Persons: Inclusion Criteria: Age 18 or over Willingness to participate in the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tetraplegia<br>Persons with Tetraplegia | |
| Paraplegia<br>Persons with Paraplegia | |
| Neurologically-intact<br>Neurologically-intact controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize microbiome composition | Characterize the distal gut microbiome within and across the three groups | Study day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit time | Measured by Smart Pill wireless motility capsule during gastric emptying | 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) | Baseline | 
| Inflammatory state | Measured by protein levels of inflammatory biomarkers in plasma | Baseline |