跳至主要内容
临床试验/NCT03794479
NCT03794479已完成不适用

Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae

研究概览

简要总结

International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or above
  • Chinese ethnicity
  • Planning to visit any places outside of Hong Kong within the next three months
  • Able to provide informed consent

排除标准

  • Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
  • Hospitalization within 3 months
  • Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
  • Pregnancy

结局指标

主要结局

Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae

时间窗: 1 year

Intestinal colonization of ESBL-producing Enterobacteriaceae is defined as the presence of ESBL in Enterobacteriaceae identified in the post-travel stool samples, in patients without these organisms detected in their stool samples before travel.

次要结局

  • Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae(1 year)

研究者

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

Grace Lui

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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