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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01858584
• Other study ID #: STDMG2013
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2013
• Last updated: May 29, 2013
• Start date: February 2013

Study information

• Verified date: May 2013
• Source: Federico II University
• Contact: Annamaria Staiano
• Phone: +39 081 7462669
• Email: staiano[@]unina.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee of the University of Naples Federico II
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Cough
• Gastroesophageal Reflux
• Regurgitation
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Italy	university of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy on GER	This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from RGE 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).	2 months	Yes
Secondary	comparison of treatments	• To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance.	2 months	Yes