Examining the Distal Gut Microbiome After Spinal Cord Injury

NCT03319225 | Completed

• 1 other identifier: 20170526
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Characterize microbiome composition

  Characterize the distal gut microbiome within and across the three groups

  Study day 7

Secondary Outcomes (3)

• Gastrointestinal transit time

  Study day 5

• Autonomic state

  Baseline

• Inflammatory state

  Baseline

Study Arms (3)

Tetraplegia

Persons with Tetraplegia

Paraplegia

Persons with Paraplegia

Neurologically-intact

Neurologically-intact controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with a spinal cord injury; Neurologically-intact controls

You may qualify if:

• Age 18-65
• ≥ 1 year post-injury
• 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.
• Self -reported history of constipation or other gastrointestinal dysfunction (e.g., extended bowel care time or difficulty in bowel emptying)
• Willingness to participate in the study

You may not qualify if:

• Currently hospitalized
• American Spinal Injury Association (AIS) D-E
• Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
• Gastrointestinal surgery ≤ 3 months prior to study
• Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump
• Concurrent use of surface functional electrical stimulation (FES)
• Neurologically-Intact Persons:
• Age 18 or over
• Willingness to participate in the study
• Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
• Gastrointestinal surgery ≤ 3 months prior to study
• Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mark S Nash, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: December 18, 2017
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)