A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Anti regurgitation infant formula
Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
Bialystok, Poland
Centrum Medyczne Promed
Krakow, Poland
GI tolerance
To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale
Time frame: 4 weeks
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