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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

October 19, 2017
October 24, 2017
June 6, 2018
December 18, 2017
December 18, 2020   (Final data collection date for primary outcome measure)
Characterize microbiome composition [ Time Frame: Study day 7 ]
Characterize the distal gut microbiome within and across the three groups
Same as current
Complete list of historical versions of study NCT03319225 on ClinicalTrials.gov Archive Site
  • Gastrointestinal transit time [ Time Frame: Study day 5 ]
    Measured by "Smart Pill" wireless motility capsule during gastric emptying
  • 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)
  • Inflammatory state [ Time Frame: Baseline ]
    Measured by protein levels of inflammatory biomarkers in plasma
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Persons with a spinal cord injury; Neurologically-intact controls
Spinal Cord Injury
Not Provided
  • Tetraplegia
    Persons with Tetraplegia
  • Paraplegia
    Persons with Paraplegia
  • Neurologically-intact
    Neurologically-intact controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Same as current
December 18, 2020
December 18, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Crystal Noller, Ph.D. 305-243-6320 cnoller@med.miami.edu
United States
 
 
NCT03319225
20170526
No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Mark S. Nash, Ph.D., FACSM, University of Miami
University of Miami
Not Provided
Principal Investigator: Mark S Nash, Ph.D. University of Miami
University of Miami
June 2018