Examining the Distal Gut Microbiome After Spinal Cord Injury

N/ACompletedNCT03319225

University of Miami5 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Cord Injury

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Persons with a Spinal Cord Injury: Inclusion Criteria: 1. Age 18-65 2. ≥ 1 year post-injury 3. 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. 4. Self -reported history of constipation or other gastrointestinal dysfunction (e.g., extended bowel care time or difficulty in bowel emptying) 5. Willingness to participate in the study Exclusion Criteria: 1. Currently hospitalized 2. American Spinal Injury Association (AIS) D-E 3. Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder 4. Gastrointestinal surgery ≤ 3 months prior to study 5. Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump 6. Concurrent use of surface functional electrical stimulation (FES) Neurologically-Intact Persons: Inclusion Criteria: 1. Age 18 or over 2. Willingness to participate in the study Exclusion Criteria: 1. Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder 2. Gastrointestinal surgery ≤ 3 months prior to study 3. Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump

Locations (1)

University of Miami Miller School of Medicine

Miami, Florida, United States

Outcomes

Primary Outcomes

Characterize microbiome composition

Characterize the distal gut microbiome within and across the three groups

Time frame: Study day 7

Secondary Outcomes

Gastrointestinal transit time

Measured by "Smart Pill" wireless motility capsule during gastric emptying

Time frame: 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)

Time frame: Baseline

Inflammatory state

Measured by protein levels of inflammatory biomarkers in plasma

Time frame: Baseline

Data from ClinicalTrials.gov

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