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