Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

NCT03273296 | Completed Phase 4

• 1 other identifier: 1341/6.00.00/2017
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Keywords

microbiota; metabolize

Outcome Measures

Primary Outcomes (2)

• Microbiome

  Change in gut microbiome from baseline to repeat assessments.

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

• Metabolome

  Change in circulating metabolome from baseline to repeat assessments.

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

Study Arms (3)

Amoxicillin

ACTIVE COMPARATOR

Drug: Amoxicillin

Azithromycin

ACTIVE COMPARATOR

Drug: Azithromycin

Vancomycin

ACTIVE COMPARATOR

Drug: Vancomycin

Interventions

Amoxicillin DRUG

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

Amoxicillin

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.

Azithromycin

Vancomycin DRUG

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

Vancomycin

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• University of California, San Diego: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Finnish Institute for Health and Welfare

Helsinki, 00271, Finland

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Amoxicillin; Azithromycin; Vancomycin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Aki Havulinna, MD, PhD

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

• Markus Perola, DSc (tech.)

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: October 15, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)