Oral use of Streptococcus salivarius K12 in children with secretory otitis media: preliminary results of a pilot, uncontrolled study

Figures & data

Figure 1 Scheme of the study.

Abbreviation: SOM, secretory otitis media.

Table 1 Demographic characteristics of the enrolled subjects

Sex	Number	Age (yr)	Weight (kg)	Height (m)	BMI (kg/m^2)	Allergy	Breastfed	PCV13	SBEA
Female	5	4.8±1.0	18.4±3.3	1.05±0.07	16.7±2.9	1	4	5	0
Male	17	5.8±2.2	24.2±6.3	1.14±0.11	18.5±2.8	7	16	15	4
Total	22	5.6±2.1	22.9±6.2	1.12±0.11	18.1±2.8	8	20	20	4

Abbreviations: BMI, body mass index; PCV13, 13-valent pneumococcal vaccine; SBEA, Streptococcus beta-hemolytic group-A (Streptococcus pyogenes); yr, year.

Table 2 Clinical outcome in children with secretory otitis media treated by oral route with Streptococcus salivarius K12

	T=0	T=90	Δ (%)a	P
AOM incidenceb	0.40	0.23	42.5	<0.01
Tone audiometry (right)	1.2±0.6	0.4±0.5	66	<0.01
Tone audiometry (left)	1.1±0.7	0.4±0.6	54.6	<0.01
Otoscopy (right)	1.5±0.9	0.9±1.0	40	<0.05
Otoscopy (left)	1.3±0.8	0.8±0.3	38.5	<0.05
Endonasal endoscopyc	70	50	28.6	<0.01
Tonsillar examination	1.9±1.1	1.2±0.8	36.8	<0.01

Notes:

a T=90 versus T=0;

b episodes/month/child;

c reported as average value of the % of obstruction, statistical analysis has been performed by using arcsin value.

Abbreviation: AOM, acute otitis media.

Table 3 Left and right tympanometry in children with secretory otitis media treated by oral route with Streptococcus salivarius K12

Left	T=0	T=90	P	Right	T=0	T=90	P
A	6	14	<0.05	A	7	13	<0.05
B	9	2	<0.05	B	10	2	<0.05
C	7	6	ns	C	5	7	ns

Notes: A = normal; B = presence of middle ear exudate; C = tubaric dysfunction.

Abbreviation: ns, not significant.

Table 4 Tolerability, compliance, and side effects in children (N=22) with secretory otitis media treated for 90 days by oral route with Streptococcus salivarius K12 as reported by parents and established by clinician

	Tolerability	Compliance	Side effects
Very good	N=13	N=16	None
Good	N=7	N=4	None
Acceptable	N=2	N=2	None
Unacceptable	N=0	N=0	None

Note: N = number of children.