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

University of Miami1 site in 1 country5 target enrollmentDecember 18, 2017

ConditionsSpinal Cord Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: University of Miami
Enrollment: 5
Locations: 1
Primary Endpoint: Characterize microbiome composition
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

December 18, 2017

End Date

January 9, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Mark S. Nash, Ph.D., FACSM

Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

•≥ 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