NCT02340182

Brief Summary

The objective of this study is to investigate the role of the gut microbiota in the systemic priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24 hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation assay) and gut microbiota composition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

July 8, 2013

Last Update Submit

January 15, 2015

Conditions

HealthySepsis

Keywords

gut floraantibioticssystemic immune responseVolunteers

Outcome Measures

Primary Outcomes (1)

  • Composite measure of Laboratory parameters for inflammatory responses.

    Ex vivo response of whole blood, isolated monocytes or neutrophils to lipopolysaccharide.

    up to 7 weeks

Other Outcomes (2)

  • Side effects will be registered using a graded scale

    up to week 7

  • A HITchip (human intestinal tract chip; 16S rRNA) analysis will be used to determine microbiome composition

    up to week 7

Study Arms (1)

Antibiotics

EXPERIMENTAL

All volunteers will self-administer the following antibiotics for 7 consecutive days (concomitantly): 1. Vancomycin 250mg 3dd2; 2. Ciprofloxacin 500mg 2dd1; 3. Metronidazole 500mg 3dd1.

Drug: VancomycinDrug: CiprofloxacinDrug: Metronidazole

Interventions

VancomycinDRUG

250mg 3dd2

Antibiotics
CiprofloxacinDRUG

500mg 2dd1

Antibiotics
MetronidazoleDRUG

500mg 3dd1

Antibiotics

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male between 18 and 35 years of age
  • Capable of giving written informed consent and able to comply with the requirements and restrictions
  • Chemistry panel without any clinically relevant abnormality
  • Normal defecation pattern (defined as \<3x/ day and \>3x/week)

You may not qualify if:

  • Major illness in the past 3 months or significant chronic medical illness;
  • History of any type of malignancy;
  • Past or current gastrointestinal disease which may influence the gut microbiota;
  • Known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV;
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities;
  • Use of tobacco products;
  • History, within 3 years, of drug abuse;
  • History of alcoholism and/or drinking more than 3 units of alcohol per day;
  • The subject has received an investigational product within three months of day 1;
  • Use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months;
  • Recent (\< 12 months) use of antibiotics (any kind, except for dermal antibiotics);
  • Allergy to antibiotics (any kind);
  • Difficulty swallowing pills;
  • Any other relevant issue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Sepsis

Interventions

VancomycinCiprofloxacinMetronidazole

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Tom Van der Poll, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 8, 2013

First Posted

January 16, 2015

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

NL(1)