Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
NCT ID: NCT02806453
Last Updated: 2016-06-21
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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UNKNOWN
PHASE4
99 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group A
Group A: Mg alginate/thickened formula
thickened formula
Mg alginate
reassurance with lifestyle changes
Group B
Group B: thickened formula/Mg alginate
thickened formula
Mg alginate
reassurance with lifestyle changes
Interventions
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thickened formula
Mg alginate
reassurance with lifestyle changes
Eligibility Criteria
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Inclusion Criteria
* infant regurgitation defined according to the Rome IV criteria
* informed consent
Exclusion Criteria
3 Months
1 Year
ALL
Yes
Sponsors
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Policlinico Hospital
OTHER
Responsible Party
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Prof. Maria Elisabetta Baldassarre
MD
Locations
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Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, , Italy
Countries
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Other Identifiers
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ALNEO1
Identifier Type: -
Identifier Source: org_study_id
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