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NCT Number: NCT03319225

Examining the Distal Gut Microbiome 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Characterize microbiome composition

    Time frame: Study day 7

    Characterize the distal gut microbiome within and across the three groups

Secondary outcomes

  1. Gastrointestinal transit time

    Time frame: Study day 5

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

  2. Autonomic state

    Time frame: Baseline

    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)

  3. Inflammatory state

    Time frame: Baseline

    Measured by protein levels of inflammatory biomarkers in plasma

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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