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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03319225

Enrollment

Registered

2017-10-24

Start date

2017-12-18

Completion date

2018-01-09

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Characterize microbiome composition	Study day 7	Characterize the distal gut microbiome within and across the three groups

Secondary

Measure	Time frame	Description
Gastrointestinal transit time	Study day 5	Measured by Smart Pill wireless motility capsule during gastric emptying
Autonomic state	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	Baseline	Measured by protein levels of inflammatory biomarkers in plasma

Countries

United States

Outcome results