Examining the Distal Gut Microbiome After Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-01-09

Brief Summary

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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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Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tetraplegia

Persons with Tetraplegia

No interventions assigned to this group

Paraplegia

Persons with Paraplegia

No interventions assigned to this group

Neurologically-intact

Neurologically-intact controls

No interventions assigned to this group

Eligibility Criteria

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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

1. Age 18 or over
2. 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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes