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

Regurgitation, Gastric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956682
• Other study ID #: University of Bari
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2013
• Last updated: March 31, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Regurgitation, Gastric

Intervention

Dietary Supplement:
• HA formula + starch + L. reuteri

Locations

Country	Name	City	State
Italy	Ospedale Pediatrico Giovanni XXIII	Bari	BA

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regurgitation	The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.	four weeks of treatment	No
Secondary	Growth	To assess whether the groups have comparable growth	Four weeks of treatment	No
Secondary	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	Four weeks treatment	No
Secondary	Gastric empty rate	To compare the ultrasound gastric empty rate	Four week treatment	No
Secondary	Digestive tolerance	To assess the infants' digestive tolerance	Four weeks treatment	No
Secondary	Stool frequency	To assess stool frequency	Four weeks treatment	No
Secondary	compliance	To assess the subject's compliance to product consumption.	four weeks intervention	No
Secondary	Financial and non-financial burden	To measure family financial and non-financial burden related with the regurgitation	Four week treatment	No