The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.
The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
342
Standard follow-on formula administered orally
Standard follow-on formula administered orally
Universitair Ziekenhuis Brussel
Brussels, Belgium
RECRUITINGFever
Number of febrile days (peak temperature of forehead at least 38.0°C)
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Absenteeism
Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Beneficial colonization
Changes in fecal microbiota by 16S rRNA Sequencing
Time frame: Stool sample collected at baseline and after 90 days intervention period
Stool consistency
Hard, formed, soft and watery stools will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Stool frequency
Number of defecations will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Caretaker´s absenteeism from work
Number of work days missed by the parents
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.