跳至主要内容
临床试验/NCT02745028
NCT02745028撤回不适用

Effect of a Single Dose of Monosodium Glutamate on Delayed Gastric Emptying in Children

Veronica Beatriz Busoni0 个研究点开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Reduced gastric emptying time

研究概览

简要总结

Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.

详细描述

There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time.

Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Months 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours

排除标准

  • •Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.

研究组 & 干预措施

With monosodium glutamate

Other

Results of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg

干预措施: Monosodium glutamate (Dietary Supplement)

结局指标

主要结局

Reduced gastric emptying time

时间窗: During the test (4 hours from intake)

Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline

次要结局

未报告次要终点

研究者

发起方
Veronica Beatriz Busoni
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Veronica Beatriz Busoni

Head of the Pediatric Gastroenterology and Hepatology Service

Hospital Italiano de Buenos Aires

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