Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
NCT ID: NCT01956682
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2014-10-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Infant formula
HA formula + starch + L. reuteri
HA formula + starch + L. reuteri
Standard Formula
Standard Infant Formula
No interventions assigned to this group
Interventions
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HA formula + starch + L. reuteri
Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Days
5 Months
ALL
Yes
Sponsors
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University of Bari
OTHER
Responsible Party
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Flavia Indrio
M.D.
Principal Investigators
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Flavia Indrio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bari
Locations
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Ospedale Pediatrico Giovanni XXIII
Bari, BA, Italy
Countries
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Other Identifiers
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University of Bari
Identifier Type: -
Identifier Source: org_study_id
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