Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Microbial Colonization Clinical Trial

Official title:

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273296
• Other study ID #: 1341/6.00.00/2017
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2017
• Last updated: April 3, 2018
• Start date: October 15, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: April 2018
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Intervention

Drug:
• Amoxicillin
Amoxicillin (po) 500 mg x 3 per day for 3 days.
• 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.
• Vancomycin
Vancomycin (po) 125 mg x 4 per day for 3 days.

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Brigham and Women's Hospital, University of California, San Diego

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome	Change in gut microbiome from baseline to repeat assessments.	Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
Primary	Metabolome	Change in circulating metabolome from baseline to repeat assessments.	Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.