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

Primary Purpose

Gastroesophageal Reflux, Regurgitation, Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Gastrotuss
thickened milk
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring GER, Alginate, Regurgitation, questionnaire

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • university of Naples Federico IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Gastrotuss

Thickened Formula

control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

comparison of treatments
• To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance.

Full Information

First Posted
May 17, 2013
Last Updated
May 29, 2013
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01858584
Brief Title
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Official Title
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Regurgitation, Vomiting, Chronic Cough
Keywords
GER, Alginate, Regurgitation, questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastrotuss
Arm Type
Experimental
Arm Description
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
Arm Title
Thickened Formula
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Gastrotuss
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
thickened milk
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy on GER
Description
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).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
comparison of treatments
Description
• To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance.
Time Frame
2 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annamaria Staiano
Phone
+39 081 7462669
Email
staiano@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Staiano
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
university of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Ummarino
Phone
348 5481267
Email
dariummarino@virgilio.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
25079477
Citation
Ummarino D, Miele E, Martinelli M, Scarpato E, Crocetto F, Sciorio E, Staiano A. Effect of magnesium alginate plus simethicone on gastroesophageal reflux in infants. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):230-5. doi: 10.1097/MPG.0000000000000521.
Results Reference
derived

Learn more about this trial

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

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