Skip to content

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03273296
Enrollment
39
Registered
2017-09-06
Start date
2017-10-15
Completion date
2017-12-15
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

Keywords

microbiota, metabolize

Brief summary

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.

Interventions

DRUGAmoxicillin

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

DRUGAzithromycin

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

DRUGVancomycin

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

Sponsors

University of California, San Diego
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Finnish Institute for Health and Welfare
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
MicrobiomeBaseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.Change in gut microbiome from baseline to repeat assessments.
MetabolomeBaseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.Change in circulating metabolome from baseline to repeat assessments.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026