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

This study has been completed.
Information provided by (Responsible Party):
Flavia Indrio, University of Bari Identifier:
First received: September 18, 2013
Last updated: March 31, 2015
Last verified: March 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Flavia Indrio, University of Bari:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Growth [ Time Frame: Four weeks of treatment ]
    To assess whether the groups have comparable growth

  • 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

  • Gastric empty rate [ Time Frame: Four week treatment ]
    To compare the ultrasound gastric empty rate

  • Digestive tolerance [ Time Frame: Four weeks treatment ]
    To assess the infants' digestive tolerance

  • Stool frequency [ Time Frame: Four weeks treatment ]
    To assess stool frequency

  • compliance [ Time Frame: four weeks intervention ]
    To assess the subject's compliance to product consumption.

  • Financial and non-financial burden [ Time Frame: Four week treatment ]
    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.

Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01956682

Ospedale Pediatrico Giovanni XXIII
Bari, BA, Italy, 70100
Sponsors and Collaborators
University of Bari
Principal Investigator: Flavia Indrio, MD University of Bari
  More Information

Responsible Party: Flavia Indrio, M.D., University of Bari Identifier: NCT01956682     History of Changes
Other Study ID Numbers: University of Bari
Study First Received: September 18, 2013
Last Updated: March 31, 2015

Additional relevant MeSH terms:
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases processed this record on May 25, 2017