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OpenTrials
Completed

NCT Number: NCT03273296

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

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.

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Key information

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Finnish Institute for Health and Welfare

Helsinki, 00271, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Amoxicillin

Drug

Amoxicillin (po) 500 mg x 3 per day for 3 days.

Azithromycin

Drug

Azithromycin (po) 500 mg x 1 on day 1, 250 mg x 1 on day 2, and 250 mg x 1 on day 3.

Vancomycin

Drug

Vancomycin (po) 125 mg x 4 per day for 3 days.

Primary outcomes

  1. Microbiome

    Time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.

    Change in gut microbiome from baseline to repeat assessments.

  2. Metabolome

    Time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.

    Change in circulating metabolome from baseline to repeat assessments.

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Brigham and Women's Hospital
  • University of California, San Diego

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 6, 2017
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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