Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
- Conditions
- Acute Otitis Media
- Interventions
- Registration Number
- NCT02935374
- Lead Sponsor
- University of Oulu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- acute symptoms of respiratory infection AND
- signs of inflammation on the tympanic membrane in otoscopy AND
- middle ear effusion found in pneumatic otoscopy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amoxicillin-Potassium Clavulanate Amoxicillin-Potassium Clavulanate 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. Macrolide Macrolide 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. Amoxicillin Amoxicillin 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.
- Primary Outcome Measures
Name Time Method Change in the relative abundance of Firmicutes in stool samples 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 Outcome Measures
Name Time Method Change in the relative abundance of Actinobacteria in stool samples 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.
Change in the relative abundance of Faecalibacterium prausnitzii in stool samples 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.
Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs) 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
Principal coordinate analysis (PCA) of fecal samples 10 days Principal coordinate analysis (PCA) of the microbiota of fecal samples 10 days after starting treatment to acute otitis media
Change in the relative abundance of Lactobacilli in stool samples 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.
Change in the relative abundance of Bacteroidetes in stool samples 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.
Change in the relative abundance of Proteobacteria in stool samples 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.
Change in the relative abundance of Verrucomicrobia in stool samples 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.
Change in the relative abundance of Bifidobacteria in stool samples 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.
Change in the diversity of fecal microbiota measured with Shannon index 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
Change in the diversity of fecal microbiota measured with Chao index 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
Presence of antimicrobial genes measured with the means of metagenomics 10 days Presence of antimicrobial genes measured with the means of metagenomics at 10 days after the diagnosis of acute otitis media
Proportion of Clostridium difficile -positive fecal samples 10 days Occurrence of Clostridium difficile in fecal samples 10 days after the diagnosis of acute otitis media
Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains 10 days Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains 10 days after the diagnosis of acute otitis media
Trial Locations
- Locations (1)
Mehiläinen, private practice
🇫🇮Oulu, Finland