To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation

NACompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

December 10, 2019

Primary Completion Date

May 23, 2023

Study Completion Date

May 23, 2023

Conditions
Regurgitation, GastricDiarrhea
Interventions
OTHER

milk based anti-regurgitation infant formula

Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

OTHER

Milk based infant formula

Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

Trial Locations (16)

Unknown

A.O.U. Ospedali Riuniti di Ancona, Ancona

Ospedale pediatrico Giovanni XXIII, Bari

Azienda Ospedaliera Universitaria G. Martino, Messina

Ospedale dei bambini Buzzi, Milan

Ospedale F. Del Ponte, Varese

Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k., Bialystok

Osrodek badan Klinicznych IN-VIVO sp. z o.o., Bydgoszcz

Gabinet Lekarski, Rzeszów

NZLA Michalkowice Jarosz, Siemianowice Śląskie

Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o, Tarnów

EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o, Żnin

"Communal Nonprofit Enterprise City Children's Clinical Hospital", Dnipro

"Communal Nonprofit Enterprise City Children's Clinical Hospital", Kharkiv

"Communal Nonprofit Enterprise Lviv City Children's Clinical Hospital", Lviv

"Communal Enterprise Poltava Regional Children's Clinical Hospital of Poltava Regional Council", Poltava

"Communal Non-Profit Enterprise of Sumy Regional Council Regional Children Clinical Hospita", Sumy

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nutricia Research

INDUSTRY