The interaction of antibiotics, gut flora and viruses in healthy volunteers.

Phase 1

Conditions: Resistance to anitbiotics
MedDRA version: 16.1Level: LLTClassification code 10004052Term: Bacterial resistanceSystem Organ Class: 100000004862
Therapeutic area: Body processes [G] - Biological Phenomena [G16]

Registration Number: EUCTR2013-003378-28-DK

Lead Sponsor: Department of Medicine, Køge University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Subject is between 18 and 65 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

2. Subject has taken antibiotics in the last 12 months (by self-report)
3. Subject has experienced allergic reactions to antibiotic class used in the study
4. Subject has special dietary habits (vegetarian or vegan)
5. Do not report regular bowel movements at least 5 days per week
6. Pregnant or lactating or wish to become pregnant during the period of the study.
7. Not using secure birth control

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To elucidate the dynamics of the gut metagenome upon exposure to antibiotics;Secondary Objective: To identify the role of Bacteriophages in developement of resistance to antibiotics<br>;Primary end point(s): Change in the gut metagenome ;Timepoint(s) of evaluation of this end point: 2,4,15,30,90 days after strat of antibiotic treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): antibiotic resistance determinants carried on phages;Timepoint(s) of evaluation of this end point: 2,4,15,30,90 days after strat of antibiotic treatment