Antibiotic Prophylaxis - Amoxicillin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis

Conditions
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Healthy

Intervention / Treatment
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* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin<br>All subjects receive one dose of 2 g Amoxicillin | Drug: Amoxicillin<br>* Amoxicillin<br>* Other names: Amoxicillin, Sandoz, 1 g tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of amoxicillin in saliva after one dose administration of amoxicillin |  | Day 1, 2, 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic prophylaxis