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

NCT01858584 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-05-30

No results posted yet for this study

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).

Conditions

  • Gastroesophageal Reflux
  • Regurgitation
  • Vomiting
  • Chronic Cough

Interventions

DRUG

Gastrotuss

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

DIETARY_SUPPLEMENT

thickened milk

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.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Annamaria Staiano · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858584 on ClinicalTrials.gov