Treatment of acute otitis media with probiotics in otitis-prone children-a double-blind, placebo-controlled randomised study.
OBJECTIVE
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.
Hatakka
Katja
K
Valio Ltd, R&D, FIN-00039 Helsinki, Finland. katja.hatakka@valio.fi
Blomgren
Karin
K
Pohjavuori
Sara
S
Kaijalainen
Tarja
T
Poussa
Tuija
T
Leinonen
Maija
M
Korpela
Riitta
R
Pitkäranta
Anne
A
D000208:Acute Disease; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D001936:Moraxella catarrhalis / Q000187:drug effects / Q000254:growth & development* / Q000302:isolation & purification; D009305:Nasopharynx / Q000382:microbiology*; D010033:Otitis Media / Q000188:drug therapy* / Q000453:epidemiology* / Q000382:microbiology; D019936:Probiotics / Q000627:therapeutic use*; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000188:drug therapy / Q000453:epidemiology / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D016896:Treatment Outcome