Examining the Distal Gut Microbiome After Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Persons with a spinal cord injury; Neurologically-intact controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Tetraplegia; Persons with Tetraplegia
Paraplegia; Persons with Paraplegia
Neurologically-intact; Neurologically-intact controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize microbiome composition	Characterize the distal gut microbiome within and across the three groups	Study day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal transit time	Measured by "Smart Pill" wireless motility capsule during gastric emptying	Study day 5
Autonomic state	Autonomic tone will be assessed indirectly using heart rate variability by measuring the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)	Baseline
Inflammatory state	Measured by protein levels of inflammatory biomarkers in plasma	Baseline

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Mark S Nash, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 20170526

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No