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

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Acute Otitis Media

Treatments: Drug: Amoxicillin-Potassium Clavulanate; Drug: Amoxicillin; Drug: Macrolide

Study type: Interventional

Funder types: Other

Identifiers

NCT02935374

OY20167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 4 patient groups

Amoxicillin

Active Comparator group

Description:

The children with acute otitis media will be treated with amoxicillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.

Treatment:

Drug: Amoxicillin

Amoxicillin-Potassium Clavulanate

Active Comparator group

Description:

The children with acute otitis media will be treated with amoxicillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.

Treatment:

Drug: Amoxicillin-Potassium Clavulanate

Wait and see

No Intervention group

Description:

The children with acute otitis media will be monitored without antimicrobial treatment.

Macrolide

Other group

Description:

The children with acute otitis media with known allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored as a separate group, outside randomization.

Treatment:

Drug: Macrolide