A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
Status: Completed
Location: See all (16) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21 days
Maximum Age: 2 months
Healthy Volunteers: t
View:
• Singleton infants with regurgitation who are otherwise healthy
• Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
• Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
• Aged \> 3 weeks (21 days) and \< 9 weeks (63 days) at screening
• Exclusively formula fed for ≥ 7 days before screening
• Written informed consent from the parent(s) and/or legally acceptable representative(s)
Locations
Other Locations
Italy
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
Poland
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
Ukraine
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
Time Frame
Start Date: 2019-12-10
Completion Date: 2023-05-23
Participants
Target number of participants: 103
Treatments
Experimental: Test Product
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
Active_comparator: Control Product
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
Authors
M Arciszewska
Related Therapeutic Areas
Sponsors
Leads: Nutricia Research