跳至主要内容
临床试验/NCT05473338
NCT05473338进行中(未招募)不适用

Comparison of Gut Microbial Composition and Function in CRPS Patients vs. Healthy Individuals

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
250
试验地点
1
主要终点
Gut microbiome composition

研究概览

简要总结

The purpose of this study is to investigate, for the first time, whether gut bacteria composition and function of patients with CRPS differ from those of healthy adults. Samples of stool, urine and blood will be collected from patients with CRPS and from healthy adults. The type and function of bacteria of CRPS patients will be analyzed and compared to those of healthy adults to test if potential differences could explain the mechanism/s involved with the development of CRPS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Gut microbiome composition

时间窗: 1 day

Assessment of genomic composition of the gut bacteria by differential abundance analysis will be performed using 16S rRNA (Genome-Quebec)

Presence of stool microbiota-related metabolites affecting host physiology

时间窗: 1 day

Concentration of bile acids and short-chain-fatty-acids through Metabolomics analysis (Metabolon, USA).

次要结局

  • Pittsburg Sleep Quality Index (PSQI) scores(1 day)
  • Short-form health-questionnaire (SF12) score(1 day)
  • Brief Pain Inventory (BPI) score(1 day)
  • Patient Health Questionnaire (PHQ-9) score(1 day)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Yoram Shir

Director, the Alan Edwards Pain Management Unit

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

Loading locations...

相似试验