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A nasal spray with alpha-haemolytic streptococci as long term prophylaxis against recurrent otitis media
Krister Tano1, Eva Grahn Håkansson, Stig E Holm
1Department of Clinical Sciences, Otorhinolaryngology, Umeå University, S-971 80, Luleå, Sweden. krister.tano@nll.se
Insights
A nasal spray with alpha-haemolytic streptococci (AHS) did not reduce recurrent acute otitis media (rAOM) episodes in young children. This study found no significant difference compared to placebo, indicating it
Area of Science:
- Pediatrics
- Microbiology
- Otolaryngology
Background:
- Recurrent acute otitis media (rAOM) is linked to lower nasopharyngeal alpha-haemolytic streptococci (AHS) quantities and reduced inhibitory activity against common pathogens in children.
- AHS demonstrate in vitro inhibitory activity against Streptococcus pneumoniae and non-typable Haemophilus influenzae, key otitis media (OM) pathogens.
Purpose of the Study:
- To evaluate if a nasal spray containing AHS with potent inhibitory activity could serve as an alternative to tympanostomy tube insertion for children with rAOM.
Main Methods:
- A randomized, placebo-controlled, double-blind clinical study involving 43 children under 4 years old with rAOM.
- Participants received a daily nasal spray for 4 months, with a 6-month monitoring period.
- Evaluated 16 children in the active group and 20 in the placebo group.
Main Results:
- No significant difference in the number of AOM episodes between the active (7 recurrences) and placebo (8 recurrences) groups.
- The study detected no significant changes in nasopharyngeal flora related to OM pathogens during the treatment period.
Conclusions:
- The tested nasal spray regimen is not a viable alternative to tympanostomy tubes for managing rAOM in young children.
- Future research could explore enhancing efficacy through pre-treatment antibiotics, utilizing more adhesive bacterial strains, or alternative treatment schedules.
Abstract:
Previous studies have shown that children with recurrent acute otitis media (rAOM) have significantly lower quantities of alpha-haemolytic streptococci (AHS) in the nasopharynx than healthy children. Furthermore children with otitis media have AHS with lower inhibitory activity in vitro on Streptococcus pneumoniae and non-typable Haemophilus influenzae compared with healthy children. A randomised, placebo controlled and double blind clinical study among children with rAOM was designed to determine whether or not a nasal spray, containing AHS with very good inhibitory activity on the three most common OM pathogens, could be an alternative to tympanostomy tube insertion. Forty three children under 4 years of age were included in the study. The children sprayed once daily for 4 months and were monitored for 6 months. Sixteen children in the active group and 20 children in the placebo group were evaluated. The result showed no significant differences regarding the number of episodes of AOM, with seven recurrences in the active group and eight in the placebo group. No significant changes of the nasopharyngeal flora could be detected during the study period regarding the OM pathogens. Nasal spray according to the performed schedule is not yet an alternative to tympanostomy tubes in children with rAOM. The possibility of increasing the efficacy of this ecological treatment, by using pre-treatment antibiotics, more adhesive bacteria and alternative treatment schedules is discussed.