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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Dario Ummarino, Federico II University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858584
First Posted: May 21, 2013
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dario Ummarino, Federico II University
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Dario Ummarino, Federico II University:

Primary Outcome Measures:
  • efficacy on GER [ Time Frame: 2 months ]
    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 ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dario Ummarino, Doctor, Federico II University
ClinicalTrials.gov Identifier: NCT01858584     History of Changes
Other Study ID Numbers: STDMG2013
First Submitted: May 17, 2013
First Posted: May 21, 2013
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Dario Ummarino, 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
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs