The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Ospedale Pediatrico Giovanni XXIII
Bari, BA, Italy
Regurgitation
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
Time frame: four weeks of treatment
Growth
To assess whether the groups have comparable growth
Time frame: Four weeks of treatment
Regurgitation score
To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up
Time frame: Four weeks treatment
Gastric empty rate
To compare the ultrasound gastric empty rate
Time frame: Four week treatment
Digestive tolerance
To assess the infants' digestive tolerance
Time frame: Four weeks treatment
Stool frequency
To assess stool frequency
Time frame: Four weeks treatment
compliance
To assess the subject's compliance to product consumption.
Time frame: four weeks intervention
Financial and non-financial burden
To measure family financial and non-financial burden related with the regurgitation
Time frame: Four week treatment
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