Examining the Distal Gut Microbiome After Spinal Cord Injury

Completed

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT03319225

Run by

University of Miami

People needed

5

Starts

2017-12-18

Expected to finish

2018-01-09

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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