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

Acute Otitis Media Clinical Trial

— AOMMi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935374
• Other study ID #: OY20167
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: August 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

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

Locations

Country	Name	City	State
Finland	Mehiläinen, private practice	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the relative abundance of Firmicutes in stool samples	Change in the relative abundance of Firmicutes in stool samples obtained at baseline and at 10 days after the diagnosis of acute otitis media.	Change from baseline to 10 days
Secondary	Principal coordinate analysis (PCA) of fecal samples	Principal coordinate analysis (PCA) of the microbiota of fecal samples 10 days after starting treatment to acute otitis media	10 days
Secondary	Change in the relative abundance of Actinobacteria in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Bacteroidetes in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Proteobacteria in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Verrucomicrobia in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Lactobacilli in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Bifidobacteria in stool samples	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 from baseline to 10 days
Secondary	Change in the relative abundance of Faecalibacterium prausnitzii in stool samples	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 from baseline to 10 days
Secondary	Change in the diversity of fecal microbiota measured with the number of operational taxonomic units (OTUs)	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	Change from baseline to 10 days
Secondary	Change in the diversity of fecal microbiota measured with Shannon index	Change in the diversity of fecal microbiota measured with Shannon index from baseline to 10 days after the diagnosis of acute otitis media	Change from baseline to 10 days
Secondary	Change in the diversity of fecal microbiota measured with Chao index	Change in the diversity of fecal microbiota measured with Chao index from baseline to 10 days after the diagnosis of acute otitis media	Change from baseline to 10 days
Secondary	Presence of antimicrobial genes measured with the means of metagenomics	Presence of antimicrobial genes measured with the means of metagenomics at 10 days after the diagnosis of acute otitis media	10 days
Secondary	Proportion of Clostridium difficile -positive fecal samples	Occurrence of Clostridium difficile in fecal samples 10 days after the diagnosis of acute otitis media	10 days
Secondary	Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains	Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains 10 days after the diagnosis of acute otitis media	10 days