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

Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial

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.

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