Overview

Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federico II University
Treatments:
Alginic acid
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