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.
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional). The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
346
Exclusive formula feeding with the new infant formula thickened with fibers
Exclusive formula feeding with the formula thickened with locust bean
Frequency of regurgitation
Decrease of the daily number of regurgitation between baseline and day 14
Time frame: Day 14
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