Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

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.

Inclusion Criteria:

• Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
• Age of infant between 5 days and 5 months
• NGA
• Infant exclusively formula-fed at enrollment
• Presenting regurgitation/spitting-up according to the parents' perception
• Vandenplas score of at least 2 and maximum 5
• Having obtained the subject's legal representative's written informed consent

Exclusion Criteria:

• Previous antireflux treatment
• Previous consumption of AR infant formula or external thickener
• Previous consumption of a formula with L. reuteri
• Cow's milk allergy symptoms according to medical decision
• Congenital illness or malformation that may affect growth
• Significant pre-natal and/or post-natal disease
• Newborn whose parents / caregivers cannot be expected to comply with study procedures
• Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.