Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- efficacy on GER
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Gastrotuss (Drug)
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.
干预措施: thickened milk (Dietary Supplement)
结局指标
主要结局
efficacy on GER
时间窗: 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).
次要结局
- comparison of treatments(2 months)
研究者
Dario Ummarino
Doctor
Federico II University