Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
Overview
- Phase
- Phase 3
- Intervention
- Amoxicillin
- Conditions
- Healthy
- Sponsor
- Bodil Lund
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Bodil Lund
Assoc. professor, Dentist
Karolinska University Hospital
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Age 18-45
- •Understands the study procedure and speaks Swedish and/or English
Exclusion Criteria
- •Treatment with antibiotics within the previous three months
- •Breast-feeding
- •Allergic against penicillin
- •Concomitantly participate in another medical product study
- •Treatment with any kind of medication, health food preparations or probiotics
Arms & Interventions
Amoxicillin
All subjects receive one dose of 2 g Amoxicillin
Intervention: Amoxicillin
Outcomes
Primary Outcomes
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
Time Frame: Day 1, 2, 5, 10, 17 and 24
Secondary Outcomes
- Concentration of amoxicillin in saliva after one dose administration of amoxicillin(Day 1, 2, 5)