Effect of probiotic lozenges on improvement in tympanometric classification within 12 weeks in children aged 3-6 years with adenoid hypertrophy and otitis media with effusion undergoing non-surgical management: a randomized controlled trial.

SSK12 probiotic lozenges significantly increased the probability of tympanogram classification improvement compared with placebo.

• The primary outcome was child-level tympanogram improvement defined as 'B/C→A' at week 12.
• Adjusted odds ratio for tympanogram improvement was aOR=1.87 (P=0.003).
• Benefits were consistent across subgroups with all p(interaction)>0.05, indicating no significant effect modification.
• All participants received standard non-surgical management in addition to either SSK12 or placebo lozenges.

Ear-level analyses confirmed the tympanometric advantage of SSK12 over placebo.

• All ear-level adjusted odds ratios were greater than 1 with P<0.05.
• Moderate intra-child correlation was observed (ρ≈0.33), addressed using generalized estimating equations (GEE).
• Analyses accounted for the clustered nature of bilateral ear data within individual children.

SSK12 produced significant group × time interactions for tympanometric parameters.

• Positive changes were observed in ΔTPP (tympanometric peak pressure) and ΔYtm (peak admittance), both P<0.01.
• Decreased ΔTW (tympanometric width) was observed in the SSK12 group (P<0.01).
• Linear mixed-effects models were used to estimate time effects and interaction terms.
• All three tympanometric parameter interactions reached statistical significance at P<0.01.

SSK12 administration markedly increased probiotic colonization rates and load in the nasopharynx.

• Both colonization rate and colonization load increased significantly (P<0.001 for both).
• SSK12 lozenges contained ≥1×10⁹ CFU per lozenge, administered daily for 12 weeks.
• Nasopharyngeal microbiota profiles were assessed as part of secondary analyses.

SSK12 treatment reduced nasopharyngeal loads of key otopathogens associated with OME.

• Reduced loads were observed for Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis.
• All three pathogen reductions were statistically significant at P<0.01.
• Pathogen suppression was identified as a mediating mechanism for tympanogram improvement.

SSK12 improved audiological outcomes including pure-tone average and distortion product otoacoustic emissions (DPOAE).

• The SSK12 group showed a greater decline in four-frequency pure-tone average compared to placebo (P=0.002).
• DPOAE conversion to normal was higher in the SSK12 group (aOR=2.06, P=0.001).
• Audiometric outcomes were included as secondary endpoints.

SSK12 treatment reduced the incidence of upper respiratory infections and acute otitis media.

• Incidences of upper respiratory infections were reduced compared to placebo (P<0.05).
• Incidence of acute otitis media was also reduced (P<0.05).
• Both reductions reached statistical significance.

SSK12 lozenges demonstrated a favorable safety profile with no significant adverse effects or blinding bias.

• No significant adverse effects were observed over the 12-week treatment period.
• No significant blinding bias was detected, supporting internal validity.
• The trial was designed as a single-center, randomized, double-blind, placebo-controlled RCT.
• Adherence to the lozenge regimen was described as excellent.

The study population consisted of children aged 3-6 years with adenoid hypertrophy and otitis media with effusion undergoing non-surgical management.

• The trial was conducted as a single-center study.
• Children were randomized to SSK12 or placebo lozenges for 12 weeks.
• OME is described as common among children aged 3-6 years with adenoid hypertrophy.
• Tympanogram classification served as the main clinical indicator and primary endpoint.