276
Participants
Start Date
April 18, 2018
Primary Completion Date
December 15, 2018
Study Completion Date
December 15, 2018
Biokult
"Bio-Kult Infantis® is a multi-strain formula containing a probiotic formulation comprising 7 strains of probiotics, high content of Omega-3, Vitamin D3 and Preplex® (50% FOS and 50% gum acacia).~Each sachet contains:~* Minimum 1 billion microorganisms per sachet (1 x 109CFU/g), guaranteed throughout the shelf life~* DHA + EPA: \>1mg per sachet~* Vitamin D3: 2.5mcg per sachet (50% of Nutrient Reference Value). Bio-Kult Infantis® presents itself in the form of a white powder, packaged in sachets of 1 g each"
Placebo
"IP placebo is manufactured so to contain maltodextrin DE19 and have the same organoleptic properties of the active product (similar to the study product in appearance and taste) but without active ingredient. It contains 100% maltodextrin DE19.~Moreover, placebo sachets are equal in color, shape and weight (1 g) to IP sachets."
RECRUITING
"Hospital Sandro Pertini", Roma
Lead Sponsor
Sprim Advanced Life Sciences
OTHER
Probiotics International Ltd.
INDUSTRY