Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2017-12-15

Brief Summary

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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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Detailed Description

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Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Amoxicillin

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

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

Azithromycin

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

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

Interventions

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Amoxicillin

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

Intervention Type DRUG

Azithromycin

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

Intervention Type DRUG

Vancomycin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes