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

Sponsor

Federico II University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01858584

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Regurgitation Vomiting Chronic Cough	Drug: Gastrotuss Dietary Supplement: thickened milk	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

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

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

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

No Intervention: control group

Outcome Measures

Primary Outcome Measures

efficacy on GER [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 [2 months]
• To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Months

Sexes Eligible for Study:

All

Accepts 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