Examining the Distal Gut Microbiome After Spinal Cord Injury

October 5, 2018 updated by: Mark S. Nash, Ph.D., FACSM, University of Miami

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

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Study day 7
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
Time Frame: Study day 5
Measured by "Smart Pill" wireless motility capsule during gastric emptying
Study day 5
Autonomic state
Time Frame: Baseline
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
Time Frame: Baseline
Measured by protein levels of inflammatory biomarkers in plasma
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 20170526

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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