Examining the Distal Gut Microbiome After Spinal Cord Injury

University of Miami

Status: Completed

Conditions: Spinal Cord Injury

Study type: Observational

Funder types: Other

Identifiers

NCT03319225

20170526

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

5 participants in 3 patient groups

Tetraplegia

Description:

Persons with Tetraplegia

Paraplegia

Description:

Persons with Paraplegia

Neurologically-intact

Description:

Neurologically-intact controls