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.
Antimicrobial treatment of acute otitis media has been proven efficacious in children. It has been suggested that antimicrobial treatment makes a lot of harm to intestinal microbiome and may thus have effects on the child's health and wellbeing. However, data on these changes and their magnitude is scanty. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
73
The children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
The children with acute otitis media will be treated with amoxixillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
Mehiläinen, private practice
Oulu, Finland
Change in the relative abundance of Firmicutes in stool samples
Change in the relative abundance of Firmicutes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Principal coordinate analysis (PCA) of fecal samples
Principal coordinate analysis (PCA) of the microbiota of fecal samples 10 days after starting treatment to acute otitis media
Time frame: 10 days
Change in the relative abundance of Actinobacteria in stool samples
Change in the relative abundance of Actinobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the relative abundance of Bacteroidetes in stool samples
Change in the relative abundance of Bacteroidetes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the relative abundance of Proteobacteria in stool samples
Change in the relative abundance of Proteobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the relative abundance of Verrucomicrobia in stool samples
Change in the relative abundance of Verrucomicrobia in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
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Change in the relative abundance of Lactobacilli in stool samples
Change in the relative abundance of Lactobacilli in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the relative abundance of Bifidobacteria in stool samples
Change in the relative abundance of Bifidobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the relative abundance of Faecalibacterium prausnitzii in stool samples
Change in the relative abundance of Faecalibacterium prausnitzii in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.
Time frame: Change from baseline to 10 days
Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs)
Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs) from baseline to 10 days after the diagnosis of acute otitis media
Time frame: Change from baseline to 10 days
Change in the diversity of fecal microbiota measured with Shannon index
Change in the diversity of fecal microbiota measured with Shannon index from baseline to 10 days after the diagnosis of acute otitis media
Time frame: Change from baseline to 10 days
Change in the diversity of fecal microbiota measured with Chao index
Change in the diversity of fecal microbiota measured with Chao index from baseline to 10 days after the diagnosis of acute otitis media
Time frame: Change from baseline to 10 days
Presence of antimicrobial genes measured with the means of metagenomics
Presence of antimicrobial genes measured with the means of metagenomics at 10 days after the diagnosis of acute otitis media
Time frame: 10 days
Proportion of Clostridium difficile -positive fecal samples
Occurrence of Clostridium difficile in fecal samples 10 days after the diagnosis of acute otitis media
Time frame: 10 days
Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains
Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains 10 days after the diagnosis of acute otitis media
Time frame: 10 days