Clinical trial NCT01858584: Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Official title: Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Regurgitation
Vomiting
Chronic Cough
Keywords: GER
Alginate
Regurgitation
questionnaire
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 75
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Primary outcomes This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from gastroesophageal reflux (GER) 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: efficacy on GER
timeFrame: 2 months
Secondary outcomes:
measure: comparison of treatments
timeFrame: 2 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: university of Naples Federico II
Study officials:
affiliation: Federico II University
name: Annamaria Staiano
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.