title: Colonization, safety, and tolerability study of the Streptococcus salivarius 24SMBc nasal spray for its application in upper respiratory tract infections.
abstract: Streptococcus salivarius, a non-pathogenic species and the predominant colonizer of the oral microbiota, finds a wide application in the prevention of upper respiratory tract infections, also reducing the frequency of their main pathogens. In this pilot study, the primary objective was to evaluate the safety and tolerability of a nasal spray, S. salivarius 24SMBc, as a medical device in a clinical study involving 20 healthy adult subjects. The secondary aim was to determine the ability of colonization assessed by molecular fingerprinting. Twenty healthy adult subjects, aged between 30 and 54 years, without a medical history of recurrent otitis media, were enrolled. All patient characteristics fulfilled the inclusion criteria. All subjects were treated daily for 3 days with the nasal spray containing S. salivarius 24SMBc at a concentration of 5 × 10(9) colony-forming units (CFU)/ml. The persistence of S. salivarius in the nasopharynx was investigated by the antagonism test and random amplified polymorphic DNA polymerase chain reaction (RAPD-PCR). The tolerability and safety were clinically assessed by clinical examinations during treatment. Our results demonstrate the capability of S. salivarius 24SMBc to colonize the rhinopharynx tissues in 95% of subjects and persist in 55% of them after 6 days from the last dose of the formulation, maintaining a concentration of 10(5) CFU/ml. The treatment was well tolerated by all healthy patients and no adverse effects were found. The topical application of streptococcal probiotics is a relatively undeveloped field but is becoming an attractive approach for both prevention and therapy, especially for pediatric age patients. S. salivarius 24SMBc possess characteristics making this strain suitable for use in bacteriotherapy.
authors.affiliation: LabMMAR, Department of Biomedical and Biotechnological Sciences, Section of Microbiology, University of Catania, Via Androne 81, 95124, Catania, Italy. m.santagati@unict.it.
authors.forename: M
authors.initials: M
authors.lastname: Santagati
authors.affiliation: LabMMAR, Department of Biomedical and Biotechnological Sciences, Section of Microbiology, University of Catania, Via Androne 81, 95124, Catania, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Scillato
authors.affiliation: LabMMAR, Department of Biomedical and Biotechnological Sciences, Section of Microbiology, University of Catania, Via Androne 81, 95124, Catania, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Muscaridola
authors.affiliation: LabMMAR, Department of Biomedical and Biotechnological Sciences, Section of Microbiology, University of Catania, Via Androne 81, 95124, Catania, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Metoldo
authors.affiliation: Department of Medical Sciences, Surgical and Advanced Technologies, GF Ingrassia, University of Catania, Catania, Italy.
authors.forename: I
authors.initials: I
authors.lastname: La Mantia
authors.affiliation: LabMMAR, Department of Biomedical and Biotechnological Sciences, Section of Microbiology, University of Catania, Via Androne 81, 95124, Catania, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Stefani
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage*; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D013290:Streptococcal Infections / Q000188:drug therapy*; D013291:Streptococcus / Q000187:drug effects*
chemical_list: D000900:Anti-Bacterial Agents; D059085:Nasal Sprays