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Completed

NCT Number: NCT01829529

Antibiotic Prophylaxis - Amoxicillin

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska University Hospital. Department of Dental Medicine

Stockholm, Huddinge, SE-141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

Amoxicillin

Other names: Amoxicillin, Sandoz, 1 g tablet

Primary outcomes

  1. 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

  1. Concentration of amoxicillin in saliva after one dose administration of amoxicillin

    Time frame: Day 1, 2, 5

Sponsors and collaborators

Lead sponsor

Bodil Lund

Other

Registry information

Official study title

Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 11, 2013
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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