Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence

Inclusion Criteria: * Children with at least 3 episodes of acute otitis media (AOM) within 12 months prior to study inclusion as documented in their medical records. Diagnosis criteria for AOM see study protocol * parental written consent Exclusion Criteria: * Ongoing acute otitis media or URI * Current prophylaxis/treatment for URI or AOM * Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties * Use of tympanostomy tubes * Chronic tympanic membrane perforation (TMP) * Palatine cleft * Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis * History of hypersensitivity to the investigational drug or to its ingredients. * Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator's opinion, would contraindicate study participation or compliance with protocol mandated procedures. * Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.