The effect of a common antibiotic (amoxicillin with clavulanate) on the microbiome of tonsil tissue in children with recurrent tonsillitis

Not Applicable

Recruiting

• Conditions: Tonsillitis; Infection - Studies of infection and infectious agents; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618001847202
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-14
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age 0-16 years.

History of recurrent tonsillitis.

Waitlisted to undergo tonsillectomy for recurrent tonsillitis.

Must have had previous course of Amoxicillin and Clavulanic acid without adverse effects.

Exclusion Criteria

Patients with genetic syndromes, metabolic disorders, neurologic diseases or congenital malformations will be excluded.

Patients with an anatomical abnormality of the upper aerodigestive tract.

Patients who have had antibiotics within the 6 weeks prior to surgery.

Previous adenoidectomy, tonsillectomy, or grommet insertion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the difference in the tonsillar microbiome of patients with recurrent tonsillitis who have been treated with a course of Amoxicillin and Clavulanic acid versus those who have not. A combination of bacterial 16S rRNA gene-targeted amplicon sequencing and histological techniques will be used to determine the bacterial composition and spatial distribution of bacterial microcolonies in the collected samples. Droplet digital PCR will also be performed to measure the bacterial load in each sample. [Immediately following surgery, the crypts of the right and left tonsils will be swabbed and the outcome assessed. ]

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint of this study is the difference in proportions of live/dead bacteria in tonsillar specimens of patients with recurrent tonsillitis who have been treated with a course of Amoxicillin and Clavulanic acid versus those who have not. Live/dead bacterial staining will be performed on tonsillar tissue swabs immediately following surgery.[Immediately following surgery, the crypts of the right and left tonsils will be swabbed and the outcome assessed. ]