drugset / Trial / NCT02935374

Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

NCT02935374

RandomizedParallel-groupOpen-labelOther

Summary

This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.

Timeline

Start
2016-11
Primary completion
2020-03
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 40 mg/kg
Comparator Amoxicillin-Potassium Clavulanate Unknown 45 mg/kg

Indications