Bio-Kult Infantis® in AAD Prevention in Infants

NAUnknownINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

April 18, 2018

Primary Completion Date

December 15, 2018

Study Completion Date

December 15, 2018

Conditions
Acute Otitis Media
Interventions
DIETARY_SUPPLEMENT

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"

DIETARY_SUPPLEMENT

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."

Trial Locations (1)

00157

RECRUITING

"Hospital Sandro Pertini", Roma

Sponsors
All Listed Sponsors
collaborator

Sprim Advanced Life Sciences

OTHER

lead

Probiotics International Ltd.

INDUSTRY

NCT03516409 - Bio-Kult Infantis® in AAD Prevention in Infants | Biotech Hunter | Biotech Hunter