Antibiotic Prophylaxis - Amoxicillin

Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01829529

Enrollment

Registered

2013-04-11

Start date

2013-09-30

Completion date

2016-01-31

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Antibiotic prophylaxis

Brief summary

The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.

Detailed description

A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants. Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin. The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.

Interventions

DRUGAmoxicillin

Amoxicillin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Written informed consent * Healthy * Age 18-45 * Understands the study procedure and speaks Swedish and/or English

Exclusion criteria

* Treatment with antibiotics within the previous three months * Pregnant * Breast-feeding * Allergic against penicillin * Concomitantly participate in another medical product study * Treatment with any kind of medication, health food preparations or probiotics

Design outcomes

Primary

Measure	Time frame
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.	Day 1, 2, 5, 10, 17 and 24

Secondary

Measure	Time frame
Concentration of amoxicillin in saliva after one dose administration of amoxicillin	Day 1, 2, 5

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026