Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
NCT ID: NCT01858584
Last Updated: 2013-05-30
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
NA
75 participants
INTERVENTIONAL
2013-02-28
Brief Summary
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Detailed Description
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Secondary outcomes To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance, basing on questionnaire results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Gastrotuss
Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water.
dosage:
* Infants weighing \<5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional
* Infants weighing\> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day
Gastrotuss
Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water.
dosage:
* Infants weighing \<5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional
* Infants weighing\> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day
Thickened Formula
Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat.
thickened milk
Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat.
control group
No interventions assigned to this group
Interventions
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Gastrotuss
Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water.
dosage:
* Infants weighing \<5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional
* Infants weighing\> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day
thickened milk
Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat.
Eligibility Criteria
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Inclusion Criteria
* Suggestive symptoms of gastroesophageal reflux (I-GERQ score \> 7)
* Absence of clinical evidence of allergy to cow milk protein or other allergic disorder
* No previous intake of thickened formulas, acid suppressants or drugs
* All parents or guardians must sign a document of informed consent
* Patients affected by chronic disease
* Patients affected by hepatic or renal diseases
* Patients affected by cardiac diseases
Exclusion Criteria
* Patients affected by hepatic or renal diseases
* Patients affected by cardiac diseases
* Inability or unwillingness to give informed consent
* Patients wth severe neurologic disease
* Patients affected by cow milk protein allergy
* Previous or ongoing intake of thickened formulas, acid suppressants or drugs
12 Months
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Dario Ummarino
Doctor
Principal Investigators
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Annamaria Staiano
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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university of Naples Federico II
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Ummarino D, Miele E, Martinelli M, Scarpato E, Crocetto F, Sciorio E, Staiano A. Effect of magnesium alginate plus simethicone on gastroesophageal reflux in infants. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):230-5. doi: 10.1097/MPG.0000000000000521.
Other Identifiers
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STDMG2013
Identifier Type: -
Identifier Source: org_study_id
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