Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
102
Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
Placebo comparator, once a day for 8 weeks
Health center Laško
Laško, Slovenia
Pediatrija Krebs
Maribor, Slovenia
Pediatrinja d.o.o.
Maribor, Slovenia
Zasebna otroska in solska ambulanta
Maribor, Slovenia
Health Center Nova Gorica
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
Time frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
The incidence of adverse events occuring in the experimental group compared to control group
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.
Time frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sempeter pri Gorici, Slovenia