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Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas

NCT02030912 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-01-09

No results posted yet for this study

Summary

A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites. These will involve the administration to volunteers of minocycline and amoxicillin- a control group will receive a placebo. Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse events, vital signs, will be evaluated. The objectives of metagenomic analysis are:

* To identify the in vivo molecular mechanisms responsible for antibiotic resistance and its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome analysis.
* To determine the impact of the use of antimicrobial agents on the oral resistome
* To determine the impact of the use of antimicrobial agents on the faecal resistome
* To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous oral microbiota
* To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous faecal microbiotas

Conditions

  • Antibiotic Resistant Bacteria

Interventions

DRUG

3 doses of amoxicillin daily for 7 days

DRUG

2 doses of minocycline daily for five days

OTHER

2 doses of placebo daily for five days

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Helperby Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030912 on ClinicalTrials.gov