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临床试验/NCT05670288
NCT05670288招募中不适用

Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
Neurological impairment - Injury level by ISNCSCI

研究概览

简要总结

The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline [within 6 weeks of injury], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.

详细描述

Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.

For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.

The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab

For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements [CDEs], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 [PHQ9] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-85 years of age
  • diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
  • classification of A, B, C (motor complete, incomplete).

排除标准

  • Women who are pregnant prior to consent
  • neurological impairment other than SCI
  • self-reported history of Crohn's disease or diverticulitis
  • irritable bowel syndrome
  • gastric blockage/obstruction or swallowing disorder
  • prior GI surgery
  • intrathecal pump
  • concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).
  • able to ambulate

结局指标

主要结局

Neurological impairment - Injury level by ISNCSCI

时间窗: Month 12

Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

Neurological impairment - Injury level by AIS

时间窗: Month 12

Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.

Neurological impairment - completeness of injury by AIS

时间窗: Month 12

Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.

Neurological impairment - completeness of injury by ISNCSCI

时间窗: Month 12

Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

Microbiome composition - Bacterial 16S rRNA sequincing

时间窗: Month 12

Bacterial 16S rRNA sequencing will be performed

Microbiome composition - Metagenomics

时间窗: Month 12

A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.

Gut derived metabolites

时间窗: Month 12

Blood will be collected and serum extract metabolites will be isolated

Analysis of metabolic markers to determine metabolic function

时间窗: Month 12

Blood will be collected and serum assays for metabolic markers performed

Analysis of inflammatory markers to determine Inflammatory state

时间窗: Month 12

Blood will be collected and serum assays for inflammatory markers performed

Bowel function - International Bowel Function Basic and Extended Data Set Assessment

时间窗: Month 12

International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.

Bowel function - Bristol Stool Scale

时间窗: Month 12

Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.

次要结局

  • Physical activity - CDEs(Month 12)
  • Medication List - Self-report(Month 12)
  • Supplement usage - Medical Record Review(Month 12)
  • Anxiety(Month 12)
  • Diet(Month 12)
  • Supplement usage - self-report(Month 12)
  • Physical activity - PARA-SCI(Month 12)
  • Medication List - Medical Record Review(Month 12)
  • Depression(Month 12)
  • Comorbidities(Month 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jereme Wilroy

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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