drugset / Trial / NCT02935374
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 40 mg/kg | — |
| Comparator | Amoxicillin-Potassium Clavulanate | Unknown | 45 mg/kg | — |