Table 1.

Overview of the clinical studies in pediatric populations.

Indication	Number of Studies	N (Total)	N (Probiotic Arm)	Main Outcome Measures	References
Safety
Healthy children/newborns	2	340	≈50/strain [13] 1 66 [14]	Growth parameters, adverse events and serious adverse events, sleep and crying patterns, D-lactic acid	[13,14]
Gastrointestinal function
Non-infectious diarrhea	7	1001	521	Time to symptom relief, effective rate	[15,16,17,18,19,20,21]
Rotavirus (RV)-induced diarrhea	4	394	207	Time to symptom relief, effective rate	[22,23,24,25]
Persistent diarrhea, undefined etiology	1	52	32	Time to symptom relief, effective rate	[26]
Immune system function and natural defenses
Secretory IgA, cytokines, chemokines	6	405 2	224 2	Salivary, fecal or serum levels of secretory IgA, fecal or serum levels of cytokines/chemokines	[14,18,27,28,29,30]
Common infections 3	2	213	140	Incidence of infections and related symptoms, adverse events	[31,32]
Other indications
Oral candidiasis (thrush)	1	70	35	Effective rate, recurrence	[33]
Eczema	1	76	38	Eczema Area and Severity Index (EASI) score, effective rate	[34]
Iron deficiency anemia	3	364	182	Anemia blood markers, effective rate, side effects	[35,36,37]
Necrotizing enterocolitis	1	60	30	Incidence, severity, mortality, food tolerance	[38]
Jaundice	2	1064	532	Incidence, severity (bilirubin levels)	[30,39]

¹ Study assessing individual strains. ² Not including children from De Andres et al. (2018) [28], a post hoc analysis of Manzano et al. (2007) [13] assessing single strains vs. placebo (≈50/strain). ³ Including upper respiratory tract infections, ear-nose-throat infections, and gastrointestinal symptoms.