Examining the Distal Gut Microbiome After Spinal Cord Injury



Status:Completed
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:10/11/2018
Start Date:December 18, 2017
End Date:January 9, 2018

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

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.


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
We found this trial at
1
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Phone: 305-243-6320
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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