Oral use of Streptococcus salivarius K12 in children with secretory otitis media: preliminary results of a pilot, uncontrolled study

Secretory otitis media (SOM) remains a common disease among children. Although its cause is not yet perfectly established, the pathology, often a sequel of acute otitis media (AOM), is mainly characterized by persistent fluid in the middle ear cavity. Twenty-two children with a diagnosis of SOM were treated daily for 90 days with an oral formulation containing the oral probiotic Streptococcus salivarius K12 (Bactoblis(®)). After treatment, the children were evaluated for AOM episodes and subjected to tone audiometry, tympanometry, endonasal endoscopy, otoscopy, and tonsillar examination. Subject compliance and probiotic tolerability and side effects have also been evaluated. Our results indicate a good safety profile, a substantial reduction of AOM episodes, and a positive outcome from the treatment for all of the clinical outcomes tested. We conclude that strain K12 may have a role in reducing the occurrence and/or severity of SOM in children. From our perspective, this study constitutes a starting point toward the organization of a more extensive placebo-controlled study aimed at critically appraising our preliminary observations.