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

March 31, 2015 updated by: Flavia Indrio, University of Bari
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70100
        • Ospedale Pediatrico Giovanni XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infant formula
HA formula + starch + L. reuteri
Dietary supplement: HA formula + starch + L. reuteri
Placebo Comparator: Standard Formula
Standard Infant Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regurgitation
Time Frame: 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.
four weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Flavia Indrio, MD, University of Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Bari

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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