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临床试验/NCT03273296
NCT03273296已完成4 期

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Finnish Institute for Health and Welfare1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Metabolome

研究概览

简要总结

In recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. These metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort, collected by the National Institute for Health and Welfare, we are currently determining the gut microbiome and plasma metabolome from > 7000 participants with 15 years of follow-up for various health outcomes. This is one of the largest materials of its kind world-wide. The design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in the composition of plasma metabolome. To enable conclusions which go beyond statistical associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut bacteriome with a short course of antibiotics and then examine whether a change in plasma metabolomics profile will follow. At the same time the trial will give important novel information about the effects of commonly used antibiotics on gut bacteriome and on general health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prior participation in the FINRISK 2002 survey and current residence in Helsinki metropolitan area.
  • Age range 40-74 years among men and 50-74 years among women.

排除标准

  • Known allergy to any antibiotic
  • A course of antibiotic during the past year
  • Acute infection
  • Any major illness (history of myocardial infarction, stroke, diabetes, liver or kidney disease, cancer, psychiatric disease). Uncomplicated hypertension is allowed. Likewise, statin treatment and women's hormone replacement therapy are allowed.

研究组 & 干预措施

Amoxicillin

Active Comparator

干预措施: Amoxicillin (Drug)

Azithromycin

Active Comparator

干预措施: Azithromycin (Drug)

Vancomycin

Active Comparator

干预措施: Vancomycin (Drug)

结局指标

主要结局

Metabolome

时间窗: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.

Change in circulating metabolome from baseline to repeat assessments.

Microbiome

时间窗: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.

Change in gut microbiome from baseline to repeat assessments.

次要结局

未报告次要终点

研究者

发起方
Finnish Institute for Health and Welfare
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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