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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flavia Indrio, University of Bari
ClinicalTrials.gov Identifier:
NCT01956682
First received: September 18, 2013
Last updated: March 31, 2015
Last verified: March 2015
  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


Enrollment: 132
Study Start Date: October 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956682

Locations
Italy
Ospedale Pediatrico Giovanni XXIII
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: March 31, 2015
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Laryngopharyngeal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroesophageal Reflux
Gastrointestinal Diseases
Laryngeal Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 20, 2015