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

Phase 4

Completed

• Conditions: Regurgitation, Gastric
• Interventions: Dietary Supplement: HA formula + starch + L. reuteri

• Registration Number: NCT01956682
• Lead Sponsor: University of Bari

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2014-10
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula	HA formula + starch + L. reuteri	HA formula + starch + L. reuteri

Primary Outcome Measures

Name	Time	Method
Regurgitation	four weeks of treatment	The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.

Secondary Outcome Measures

Name	Time	Method
Stool frequency	Four weeks treatment	To assess stool frequency
compliance	four weeks intervention	To assess the subject's compliance to product consumption.
Regurgitation score	Four weeks treatment	To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up
Growth	Four weeks of treatment	To assess whether the groups have comparable growth
Gastric empty rate	Four week treatment	To compare the ultrasound gastric empty rate
Financial and non-financial burden	Four week treatment	To measure family financial and non-financial burden related with the regurgitation
Digestive tolerance	Four weeks treatment	To assess the infants' digestive tolerance

Trial Locations

Locations (1)

Ospedale Pediatrico Giovanni XXIII; 🇮🇹 Bari, BA, Italy