Acute Otitis MediaPhase 4AOMMiNCT02935374
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
A Phase 4 study testing Amoxicillin, Amoxicillin-Potassium Clavulanate and Macrolide in people with Acute Otitis Media, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Amoxicillin, Amoxicillin-Potassium Clavulanate and Macrolide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2016to Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- acute symptoms of respiratory infection AND
- signs of inflammation on the tympanic membrane in otoscopy AND
- middle ear effusion found in pneumatic otoscopy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Acute Otitis Media
- Being tested
- Amoxicillin, Amoxicillin-Potassium Clavulanate, Macrolide
- Keywords
- children, intestinal microbiome, microbiota, antimicrobial course, amoxicillin, amoxicillin-clavulanate, macrolide
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
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 ClavulanateDrug
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.
MacrolideDrug
The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Active comparator | 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. Receives: Drug: Amoxicillin |
| Amoxicillin-Potassium Clavulanate | Active comparator | 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. Receives: Drug: Amoxicillin-Potassium Clavulanate |
| Wait and see | No intervention | The children with acute otitis media will be monitored without antimicrobial treatment. |
| Macrolide | Other | 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. Receives: Drug: Macrolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 10 days
Secondary outcomes (14)
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
Measured: 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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.
Measured: Change from baseline to 10 days
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
Measured: Change from baseline to 10 days
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
Measured: Change from baseline to 10 days
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
Measured: Change from baseline to 10 days
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
Measured: 10 days
Proportion of Clostridium difficile -positive fecal samples
Occurrence of Clostridium difficile in fecal samples 10 days after the diagnosis of acute otitis media
Measured: 10 days
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935374
- Sponsor's protocol ID
- OY20167
- Acronym
- AOMMi
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2016
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02935374
- Acronym / sponsor ID
- AOMMi / OY20167
- Conditions
- Acute Otitis Media
- Keywords
- children, intestinal microbiome, microbiota, antimicrobial course, amoxicillin, amoxicillin-clavulanate, macrolide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Nov 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Active comparator | Drug: AmoxicillinThe children with acute otitis media will be treated with amoxicillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days. |
| Amoxicillin-Potassium Clavulanate | Active comparator | Drug: Amoxicillin-Potassium ClavulanateThe 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. |
| Wait and see | No intervention | –The children with acute otitis media will be monitored without antimicrobial treatment. |
| Macrolide | Other | Drug: MacrolideThe 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. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- acute symptoms of respiratory infection AND
- signs of inflammation on the tympanic membrane in otoscopy AND
- middle ear effusion found in pneumatic otoscopy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinThe children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days. | Drug | Amoxicillin |
| Amoxicillin-Potassium ClavulanateThe 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. | Drug | Amoxicillin-Potassium Clavulanate |
| MacrolideThe children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately | Drug | Macrolide |
Primary outcome
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.
14 secondary outcomes
Principal coordinate analysis (PCA) of fecal samples
Time frame: 10 days
Change in the relative abundance of Actinobacteria in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Bacteroidetes in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Proteobacteria in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Verrucomicrobia in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Lactobacilli in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Bifidobacteria in stool samples
Time frame: Change from baseline to 10 days
Change in the relative abundance of Faecalibacterium prausnitzii in stool samples
Time frame: Change from baseline to 10 days
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 Shannon index
Time frame: Change from baseline to 10 days
Change in the diversity of fecal microbiota measured with Chao index
Time frame: Change from baseline to 10 days
Presence of antimicrobial genes measured with the means of metagenomics
Time frame: 10 days
Proportion of Clostridium difficile -positive fecal samples
Time frame: 10 days
Proportion of fecal samples with Extended Spectrum Beta-Lactamase -positive strains
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin, Amoxicillin-Potassium Clavulanate and Macrolide in people with Acute Otitis Media, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the relative abundance of Firmicutes in stool samples (time frame: Change from baseline to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.