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

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Collaborator: Oulu University Hospital
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Clavulanic Acid; Clavulanic Acids

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