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

Primary Purpose

Regurgitation, Gastric

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
HA formula + starch + L. reuteri
Sponsored by
University of Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regurgitation, Gastric

Eligibility Criteria

5 Days - 5 Months (Child)All SexesAccepts 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.

Sites / Locations

  • Ospedale Pediatrico Giovanni XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Infant formula

Standard Formula

Arm Description

HA formula + starch + L. reuteri

Standard Infant Formula

Outcomes

Primary Outcome Measures

Regurgitation
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

Growth
To assess whether the groups have comparable growth
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
Gastric empty rate
To compare the ultrasound gastric empty rate
Digestive tolerance
To assess the infants' digestive tolerance
Stool frequency
To assess stool frequency
compliance
To assess the subject's compliance to product consumption.
Financial and non-financial burden
To measure family financial and non-financial burden related with the regurgitation

Full Information

First Posted
September 18, 2013
Last Updated
March 31, 2015
Sponsor
University of Bari
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1. Study Identification

Unique Protocol Identification Number
NCT01956682
Brief Title
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Official Title
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bari

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regurgitation, Gastric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infant formula
Arm Type
Active Comparator
Arm Description
HA formula + starch + L. reuteri
Arm Title
Standard Formula
Arm Type
Placebo Comparator
Arm Description
Standard Infant Formula
Intervention Type
Dietary Supplement
Intervention Name(s)
HA formula + starch + L. reuteri
Primary Outcome Measure Information:
Title
Regurgitation
Description
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
Secondary Outcome Measure Information:
Title
Growth
Description
To assess whether the groups have comparable growth
Time Frame
Four weeks of treatment
Title
Regurgitation score
Description
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
Title
Gastric empty rate
Description
To compare the ultrasound gastric empty rate
Time Frame
Four week treatment
Title
Digestive tolerance
Description
To assess the infants' digestive tolerance
Time Frame
Four weeks treatment
Title
Stool frequency
Description
To assess stool frequency
Time Frame
Four weeks treatment
Title
compliance
Description
To assess the subject's compliance to product consumption.
Time Frame
four weeks intervention
Title
Financial and non-financial burden
Description
To measure family financial and non-financial burden related with the regurgitation
Time Frame
Four week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Indrio, MD
Organizational Affiliation
University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Pediatrico Giovanni XXIII
City
Bari
State/Province
BA
ZIP/Postal Code
70100
Country
Italy

12. IPD Sharing Statement

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

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