Status:
UNKNOWN
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Lead Sponsor:
Federico II University
Conditions:
Gastroesophageal Reflux
Regurgitation
Eligibility:
All Genders
Up to 12 years
Phase:
NA
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 p...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01858584
Start Date
February 1 2013
Last Update
May 30 2013
Active Locations (1)
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1
university of Naples Federico II
Naples, Italy, 80131