NCT03319225已完成不适用
A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Characterize microbiome composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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:
- •Inclusion Criteria:
- •Age 18 or over
- •Willingness to participate in the study
- •Exclusion Criteria:
- •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
结局指标
主要结局
Characterize microbiome composition
时间窗: Study day 7
Characterize the distal gut microbiome within and across the three groups
次要结局
- Gastrointestinal transit time(Study day 5)
- Autonomic state(Baseline)
- Inflammatory state(Baseline)
研究者
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami
研究点 (1)
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