NCT01829529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

April 9, 2013

Last Update Submit

September 1, 2016

Conditions

Healthy

Keywords

Antibiotic prophylaxis

Outcome Measures

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.

    Day 1, 2, 5, 10, 17 and 24

Secondary Outcomes (1)

  • Concentration of amoxicillin in saliva after one dose administration of amoxicillin

    Day 1, 2, 5

Study Arms (1)

Amoxicillin

EXPERIMENTAL

All subjects receive one dose of 2 g Amoxicillin

Drug: Amoxicillin

Interventions

AmoxicillinDRUG

Amoxicillin

Also known as: Amoxicillin, Sandoz, 1 g tablet
Amoxicillin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital. Department of Dental Medicine

Stockholm, Huddinge, SE-141 86, Sweden

Location

MeSH Terms

Interventions

AmoxicillinTablets

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Margareta Hultin, Dentist

    Department of Dental Medicine, Karolinska Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. professor, Dentist

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

January 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-09

Locations

SE(1)