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

University of Bari

Status and phase

Completed

Phase 4

Conditions

Regurgitation, Gastric

Treatments

Dietary Supplement: HA formula + starch + L. reuteri

Study type

Interventional

Funder types

Other

Identifiers

NCT01956682

University of Bari

Details and patient eligibility

About

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.

Full description

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.

Enrollment

132 patients

Sex

All

Ages

5 days to 5 months old

Volunteers

Accepts Healthy Volunteers

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.