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Completed

NCT Number: NCT02935374

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

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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mehiläinen, private practice

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

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.

Amoxicillin-Potassium Clavulanate

Drug

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.

Macrolide

Drug

The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately

Primary outcomes

  1. Change in the relative abundance of Firmicutes in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Firmicutes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

Secondary outcomes

  1. Principal coordinate analysis (PCA) of fecal samples

    Time frame: 10 days

    Principal coordinate analysis (PCA) of the microbiota of fecal samples 10 days after starting treatment to acute otitis media

  2. Change in the relative abundance of Actinobacteria in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Actinobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  3. Change in the relative abundance of Bacteroidetes in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Bacteroidetes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  4. Change in the relative abundance of Proteobacteria in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Proteobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  5. Change in the relative abundance of Verrucomicrobia in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Verrucomicrobia in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  6. Change in the relative abundance of Lactobacilli in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Lactobacilli in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  7. Change in the relative abundance of Bifidobacteria in stool samples

    Time frame: Change from baseline to 10 days

    Change in the relative abundance of Bifidobacteria in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.

  8. Change in the relative abundance of Faecalibacterium prausnitzii in stool samples

    Time frame: Change from baseline to 10 days

    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.

  9. Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs)

    Time frame: Change from baseline to 10 days

    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

  10. Change in the diversity of fecal microbiota measured with Shannon index

    Time frame: Change from baseline to 10 days

    Change in the diversity of fecal microbiota measured with Shannon index from baseline to 10 days after the diagnosis of acute otitis media

  11. Change in the diversity of fecal microbiota measured with Chao index

    Time frame: Change from baseline to 10 days

    Change in the diversity of fecal microbiota measured with Chao index from baseline to 10 days after the diagnosis of acute otitis media

  12. Presence of antimicrobial genes measured with the means of metagenomics

    Time frame: 10 days

    Presence of antimicrobial genes measured with the means of metagenomics at 10 days after the diagnosis of acute otitis media

  13. Proportion of Clostridium difficile -positive fecal samples

    Time frame: 10 days

    Occurrence of Clostridium difficile in fecal samples 10 days after the diagnosis of acute otitis media

  14. Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains

    Time frame: 10 days

    Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains 10 days after the diagnosis of acute otitis media

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

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

Acronym: AOMMi

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2016
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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