Status:
COMPLETED
Examining the Distal Gut Microbiome After Spinal Cord Injury
Lead Sponsor:
University of Miami
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Persons with a Spinal Cord Injury:
- 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
- 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
Key Trial Info
Start Date :
December 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 9 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03319225
Start Date
December 18 2017
End Date
January 9 2018
Last Update
October 9 2018
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136