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Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Primary Purpose

Microbial Colonization

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Amoxicillin
Azithromycin
Vancomycin
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbial Colonization focused on measuring microbiota, metabolize

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Amoxicillin

Azithromycin

Vancomycin

Arm Description

Outcomes

Primary Outcome Measures

Microbiome
Change in gut microbiome from baseline to repeat assessments.
Metabolome
Change in circulating metabolome from baseline to repeat assessments.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2017
Last Updated
April 3, 2018
Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of California, San Diego, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03273296
Brief Title
Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Official Title
Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of California, San Diego, Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
microbiota, metabolize

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Title
Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Amoxicillin (po) 500 mg x 3 per day for 3 days.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin (po) 125 mg x 4 per day for 3 days.
Primary Outcome Measure Information:
Title
Microbiome
Description
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.
Title
Metabolome
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Perola, MD, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Health and Welfare
City
Helsinki
ZIP/Postal Code
00271
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

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