Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
1 other identifier
interventional
75
1 country
1
Brief Summary
The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedMay 30, 2013
May 1, 2013
10 months
May 17, 2013
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy on GER
This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from RGE the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of GER (I-GERQ Annex A).
2 months
Secondary Outcomes (1)
comparison of treatments
2 months
Study Arms (3)
Gastrotuss
EXPERIMENTALGastrotuss 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
ACTIVE COMPARATORMilk 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 INTERVENTIONInterventions
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
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
You may qualify if:
- Age \< 1 year
- 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
You may not qualify if:
- Patients affected by chronic disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university of Naples Federico II
Naples, 80131, Italy
Related Publications (1)
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.
PMID: 25079477DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annamaria Staiano
Federico II University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Last Updated
May 30, 2013
Record last verified: 2013-05