Treatment of acute otitis media with probiotics in otitis-prone children—A double-blind, placebo-controlled randomised study

Summary Background & aims To examine whether probiotics would reduce the occurrence or duration of acute otitis media (AOM), or the nasopharyngeal carriage of otitis pathogens in otitis-prone children. Methods During this double-blind, placebo-controlled, randomised, 24-week intervention, 309 otitis-prone children (10 months–6 years) consumed either one probiotic capsule ( Lactobacillus rhamnosus GG and LC705, Bifidobacterium breve 99 and Propionibacterium freudenreichii JS) ( n =155) or placebo ( n =154) daily. Clinical examinations were carried out and nasopharyngeal samples taken three times. Parents recorded the symptoms of upper respiratory infection (URI) in a diary. Results Probiotic treatment did not reduce the occurrence (probiotic vs. placebo: 72% vs. 65%, OR=1.48, 95% CI 0.87–2.52, p =n.s.) or the recurrence (⩾ three) of AOM episodes (18% vs. 17%, OR=1.04, 95% CI 0.55–1.96, p =n.s.). The median duration of AOM episodes was 5.6 (IQR 3.5–9.4) vs. 6.0 (IQR 4.0–10.5) days, respectively ( p = n.s.). There was a tendency showing a reduction in the occurrence of recurrent (⩾4 to ⩾6) respiratory infections in the probiotic group (OR for ⩾4 URIs: 0.56, 95%CI 0.31–0.99, p =0.046; OR for ⩾6 URIs: 0.59, 95% CI 0.34 to 1.03, p =n.s.). Probiotics did not affect the carriage of Streptococcus pneumoniae or Haemophilus influenzae , but increased the prevalence of Moraxella catarrhalis (OR=1.79, 95% CI 1.06–3.00, p =0.028). Conclusions Probiotics did not prevent the occurrence of AOM or the nasopharyngeal carriage of otitis pathogens in otitis-prone children. A tendency showing a reduction in recurrent respiratory infections must be confirmed in further studies.