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

This study is not yet open for participant recruitment.
Verified October 2013 by University of Bari
Sponsor:
Information provided by (Responsible Party):
Flavia Indrio, University of Bari
ClinicalTrials.gov Identifier:
NCT01956682
First received: September 18, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Regurgitation, Gastric
Dietary Supplement: HA formula + starch + L. reuteri
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • Regurgitation [ Time Frame: four weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four weeks of treatment ] [ Designated as safety issue: No ]
    To assess whether the groups have comparable growth

  • Regurgitation score [ Time Frame: Four weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four week treatment ] [ Designated as safety issue: No ]
    To compare the ultrasound gastric empty rate

  • Digestive tolerance [ Time Frame: Four weeks treatment ] [ Designated as safety issue: No ]
    To assess the infants' digestive tolerance

  • Stool frequency [ Time Frame: Four weeks treatment ] [ Designated as safety issue: No ]
    To assess stool frequency

  • compliance [ Time Frame: four weeks intervention ] [ Designated as safety issue: No ]
    To assess the subject's compliance to product consumption.

  • Financial and non-financial burden [ Time Frame: Four week treatment ] [ Designated as safety issue: No ]
    To measure family financial and non-financial burden related with the regurgitation


Estimated Enrollment: 132
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infant formula
HA formula + starch + L. reuteri
Dietary Supplement: HA formula + starch + L. reuteri
Placebo Comparator: Standard Formula
Standard Infant 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.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01956682

Contacts
Contact: Flavia Indrio, MD f.indrio@alice.it

Locations
Italy
Ospedale Pediatrico Giovanni XXIII Not yet recruiting
Bari, BA, Italy, 70100
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Flavia Indrio, MD University of Bari
  More Information

No publications provided

Responsible Party: Flavia Indrio, M.D., University of Bari
ClinicalTrials.gov Identifier: NCT01956682     History of Changes
Other Study ID Numbers: University of Bari
Study First Received: September 18, 2013
Last Updated: October 7, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Regurgitation, Gastric
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014