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Examining the Distal Gut Microbiome After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03319225
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami

Brief Summary:
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.

Condition or disease
Spinal Cord Injury

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Characterize microbiome composition [ Time Frame: Study day 7 ]
    Characterize the distal gut microbiome within and across the three groups


Secondary Outcome Measures :
  1. Gastrointestinal transit time [ Time Frame: Study day 5 ]
    Measured by "Smart Pill" wireless motility capsule during gastric emptying

  2. 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)

  3. Inflammatory state [ Time Frame: Baseline ]
    Measured by protein levels of inflammatory biomarkers in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Persons with a spinal cord injury; Neurologically-intact controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319225


Contacts
Contact: Crystal Noller, Ph.D. 305-243-6320 cnoller@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Crystal Noller, Ph.D.    305-243-6320    cnoller@med.miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, Ph.D. University of Miami

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03319225     History of Changes
Other Study ID Numbers: 20170526
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System