NCT02127749

Brief Summary

The purpose of this study is to determine whether treatment with antibiotics, which harm the gut flora, causes the immune system to be less effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

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

First Submitted

Initial submission to the registry

April 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

April 28, 2014

Last Update Submit

December 29, 2015

Conditions

Endotoxemia

Keywords

antibioticsgut microbiotaendotoxemiainnate immunity

Outcome Measures

Primary Outcomes (1)

  • Cytokine production in blood

    within 8 hours after LPS administration

Study Arms (2)

Control

EXPERIMENTAL

Subjects are not pretreated with antibiotics Subjects receive 2 ng/kg endotoxin intravenously

Drug: Endotoxin

Antibiotics

EXPERIMENTAL

Subjects are pretreated with broad-spectrum antibiotics: Vancomycin, Metronidazole, Ciprofloxacin Subjects receive 2 ng/kg endotoxin intravenously

Drug: EndotoxinDrug: Vancomycin, Metronidazole, Ciprofloxacin

Interventions

EndotoxinDRUG

Both groups will receive 2 ng/kg LPS (endotoxin) intravenously

Also known as: LPS
AntibioticsControl
Vancomycin, Metronidazole, CiprofloxacinDRUG

ciprofloxacin 500mg 2 times per day, vancomycin 500mg 3 times per day metronidazole 500mg 3 times per day All together during 7 days

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
  • Chemistry panel without any clinically relevant abnormality
  • Normal defecation pattern

You may not qualify if:

  • Major illness in the past 3 months or any chronic medical illness
  • History of any type of malignancy
  • Past or current gastrointestinal disease
  • Known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV antibody 1 or 2
  • Current or chronic history of liver disease
  • Subject uses tobacco products
  • History, within 3 years, of drug abuse
  • History of alcoholism
  • Any clinically relevant abnormality on the 12-lead ECG
  • The subject has received an investigational product within three months
  • Use of prescription or non-prescription drugs
  • Use of antibiotics within 12 months
  • Known allergy to antibiotics
  • Subject has difficultly in donating blood or accessibility of a vein in left or right arm.
  • Subject has donated more than 350 mL of blood in last 3 months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (2)

  • Haak BW, Lankelma JM, Hugenholtz F, Belzer C, de Vos WM, Wiersinga WJ. Long-term impact of oral vancomycin, ciprofloxacin and metronidazole on the gut microbiota in healthy humans. J Antimicrob Chemother. 2019 Mar 1;74(3):782-786. doi: 10.1093/jac/dky471.

    PMID: 30418539DERIVED

  • Lankelma JM, Cranendonk DR, Belzer C, de Vos AF, de Vos WM, van der Poll T, Wiersinga WJ. Antibiotic-induced gut microbiota disruption during human endotoxemia: a randomised controlled study. Gut. 2017 Sep;66(9):1623-1630. doi: 10.1136/gutjnl-2016-312132. Epub 2016 Jun 15.

    PMID: 27307305DERIVED

MeSH Terms

Conditions

Endotoxemia

Interventions

EndotoxinsVancomycinMetronidazoleCiprofloxacin

Condition Hierarchy (Ancestors)

BacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bacterial ToxinsToxins, BiologicalBiological FactorsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • W. J. Wiersinga, MD, PhD

    Academic Medical Centre, Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 1, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

NL(1)