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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Federico II University
Sponsor:
Information provided by (Responsible Party):
Dario Ummarino, Federico II University
ClinicalTrials.gov Identifier:
NCT01858584
First received: May 17, 2013
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Gastroesophageal Reflux
Regurgitation
Vomiting
Chronic Cough
Drug: Gastrotuss
Dietary Supplement: thickened milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • efficacy on GER [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • comparison of treatments [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    • To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance.


Estimated Enrollment: 75
Study Start Date: February 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Active Comparator: Thickened Formula
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.
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.
No Intervention: control group

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 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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858584

Contacts
Contact: Annamaria Staiano +39 081 7462669 staiano@unina.it

Locations
Italy
university of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Dario Ummarino    348 5481267    dariummarino@virgilio.it   
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Annamaria Staiano Federico II University
  More Information

No publications provided

Responsible Party: Dario Ummarino, Doctor, Federico II University
ClinicalTrials.gov Identifier: NCT01858584     History of Changes
Other Study ID Numbers: STDMG2013
Study First Received: May 17, 2013
Last Updated: May 29, 2013
Health Authority: Italy: Ethics Committee of the University of Naples Federico II

Keywords provided by Federico II University:
GER
Alginate
Regurgitation
questionnaire

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vomiting
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Alginic acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014