Clinical trial NCT02935374: Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
Official title: Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Otitis Media
Keywords: children
intestinal microbiome
microbiota
antimicrobial course
amoxicillin
amoxicillin-clavulanate
macrolide
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2016-10-17
Enrollment: 73
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* acute symptoms of respiratory infection AND
* signs of inflammation on the tympanic membrane in otoscopy AND
* middle ear effusion found in pneumatic otoscopy

Exclusion Criteria:

* Suspected or proven complication of acute otitis media (for example acute mastoiditis or perforated tympanic membrane)
* Severe acute otitis media: severe pain and fever \> 39 degrees C
* Bilateral acute otitis media in a child younger than 2 years
* Primary or secondary immunodeficiency or Downs syndrome
* Impaired general condition or suspected severe bacterial infection
* Allergy to both amoxicillin and macrolide
* Acute otorrhea through tympanostomy tube
* Antimicrobial treatment ongoing or during previous 7 days

Primary outcomes:
measure: Change in the relative abundance of Firmicutes in stool samples
timeFrame: Change from baseline to 10 days
Secondary outcomes:
measure: Principal coordinate analysis (PCA) of fecal samples
timeFrame: 10 days
measure: Change in the relative abundance of Actinobacteria in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Bacteroidetes in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Proteobacteria in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Verrucomicrobia in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Lactobacilli in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Bifidobacteria in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the relative abundance of Faecalibacterium prausnitzii in stool samples
timeFrame: Change from baseline to 10 days
measure: Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs)
timeFrame: Change from baseline to 10 days
measure: Change in the diversity of fecal microbiota measured with Shannon index
timeFrame: Change from baseline to 10 days
measure: Change in the diversity of fecal microbiota measured with Chao index
timeFrame: Change from baseline to 10 days
measure: Presence of antimicrobial genes measured with the means of metagenomics
timeFrame: 10 days
measure: Proportion of Clostridium difficile -positive fecal samples
timeFrame: 10 days
measure: Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains
timeFrame: 10 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Mehiläinen, private practice
Study officials:
References: