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Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Sponsor: United Pharmaceuticals
Summary
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
Official title: Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
Key Details
Gender
All
Age Range
2 Weeks - 4 Months
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2023-03-17
Completion Date
2026-12-03
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Experimental Infant formula
Exclusive formula feeding with the new infant formula thickened with fibers
Infant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean
Locations (12)
Center_14
Namur, Belgium
Center_15
Thuin, Belgium
Center_09
Castelnau-le-Lez, France
Center_02
Étampes, France
Center_05
Libourne, France
Centre_10
Maromme, France
Center_16
Nice, France
Center_08
Vincennes, France
Center_01
Athens, Greece
Center_11
Thessaloniki, Greece
Center_12
Naples, Italy
Center_13
Naples, Italy