Spray Probiotic Treatment Effective in Children With Secretory Otitis Media

Alice Goodman

February 19, 2009

February 19, 2009 — Nasal spray probiotic treatment with Streptococcus sanguinis appears to be effective against long-standing secretory otitis media (SOM), potentially sparing children from surgical tube placement in the middle ear, according to a pilot study reported in the February issue of the Archives of Diseases of Childhood.

"Otitis-prone children carry more bacterial pathogens in their nasopharyngeal flora but fewer viridans streptococci. Some strains of viridans streptococci depress the growth of pathogenic bacteria in vitro," write Susann Skovbjerg, from the University of Gothenburg, Sweden, and colleagues. "The present double-blind pilot/preliminary study was designed to investigate whether nasal bacterial spray treatment could be clinically effective in children with established SOM."

The double-blind, preliminary study included 60 children aged 1 to 8 years (median, 32 months) with long-standing SOM scheduled for surgical placement of tubes in the middle ear. These children were randomly assigned to 10 days of treatment with 2 sprays per nostril twice daily of S sanguinis (n = 19), Lactobacillus rhamnosus (n = 18), or placebo (n = 17). Six patients were excluded from the analysis due to noncompliance (n = 3) or the development of acute OM (n = 3). The children received daily treatments until their scheduled surgeries 10 days after the start of therapy.

On day 0 and day 10, patients were examined clinically, and samples were obtained from the nasopharynx and middle ear fluid for further study.

Spray treatment with S sanguinis achieved significant or complete clinical recovery ("much better" or "cured") in 7 of 19 patients compared with 1 of 17 patients in the placebo group (P = .044). Three of 18 patients treated with L rhamnosus were "cured" or "much better," and another 6 showed "some improvement," but these effects were not statistically significant.

None of the treatment groups reported any adverse effects.

The authors had hoped that the samples of nasopharyngeal flora and middle ear fluid would yield some answers as to the mechanism of action of probiotic spray treatment effectiveness. However, spray treatment did not alter the composition of the nasopharyngeal flora or the cytokine pattern observed in the middle ear fluid, with the exception of a higher level of interleukin 8 found in the nasopharynx of children treated with L rhamnosus.

The researchers speculate that "spray treatment with live bacteria might stimulate innate defences promoting clearance of remaining bacteria from the middle ear. Although there was no relationship between cytokine secretion in the nasopharynx and clinical outcome, we take this as evidence that innate defence mechanisms can be activated by nasal spray bacteriotherapy."

The authors cited 1 potential limitation of their preliminary study. They said that although the clinical examination can be criticized for being subjective, it was carried out by an experienced ear, nose, and throat specialist blinded to the treatment of the children.

"Our results indicate that spray treatment with viridans streptococci in children with SOM can diminish the amount of fluid in the middle ear, thus reducing hearing problems and rendering surgery unnecessary in many cases," the authors conclude. "The mechanism for the effect remains to be elucidated."

The study was supported by the Ekhaga Foundation, the Wilhelm and Martina Lundgrens Science Foundation, and Sahlgrenska University Hospital Funds. Three of the coauthors hold stock in the company Essum AB, which produces the probiotic strains used in the study and holds a patent on L rhamnosus.

Arch Dis Child. 2009;94:92–98.

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