Examining the Distal Gut Microbiome After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319225
• Other study ID #: 20170526
• Status: Completed
• Start date: December 18, 2017
• Est. completion date: January 9, 2018

Study information

• Verified date: October 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 9, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize microbiome composition	Characterize the distal gut microbiome within and across the three groups	Study day 7
Secondary	Gastrointestinal transit time	Measured by "Smart Pill" wireless motility capsule during gastric emptying	Study day 5
Secondary	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
Secondary	Inflammatory state	Measured by protein levels of inflammatory biomarkers in plasma	Baseline