A Phase 4 interventional study of Amoxicillin and Azithromycin in Microbial Colonization, sponsored by Finnish Institute for Health and Welfare. Completed at 1 site in Finland. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Finnish Institute for Health and Welfare · Phase 4, Interventional, and Basic science
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.
Exclusion Criteria:
Drug: Amoxicillin
Drug: Azithromycin
Drug: Vancomycin
Amoxicillin (po) 500 mg x 3 per day for 3 days.
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 (po) 125 mg x 4 per day for 3 days.
Microbiome
Change in gut microbiome from baseline to repeat assessments.
Time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
Metabolome
Change in circulating metabolome from baseline to repeat assessments.
Time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
Plan to share: Yes
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Finnish Institute for Health and Welfare