Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02935374
Study type Interventional
Source University of Oulu
Contact
Status Completed
Phase Phase 4
Start date November 2016
Completion date March 2020

See also
  Status Clinical Trial Phase
Completed NCT02092454 - Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media Phase 2
Completed NCT01202578 - Evaluation of the Tympanostomy Tube Delivery System Phase 2/Phase 3
Withdrawn NCT00502450 - Is There Hearing Loss After Acute Mastoiditis N/A
Completed NCT04296448 - Evaluation of Cellphone Based Otoscopy in Pediatric Patients N/A
Terminated NCT05651633 - Analgesic Ear Drops for Children With Acute Otitis Media Phase 3
Completed NCT01941381 - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
Completed NCT02345447 - Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence Phase 3
Recruiting NCT01214538 - Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children N/A
Completed NCT03614117 - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) N/A
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Completed NCT02918773 - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) N/A
Completed NCT02567747 - Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Completed NCT02567825 - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media N/A
Completed NCT02037893 - Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media Phase 2
Completed NCT00578773 - A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea Phase 2
Completed NCT00377260 - Acute Otitis Media (AOM) Therapy Trial in Young Children Phase 4
Completed NCT00645112 - A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media Phase 4
Completed NCT00368823 - A Trial of Point of Care Information in Ambulatory Pediatrics Phase 3
Completed NCT01272999 - Impact of Prevnar 13 on Ear Infections in Children
Completed NCT01031082 - Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children N/A