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临床试验/NCT03777787
NCT03777787已完成不适用

The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in number of TLESRs

研究概览

简要总结

Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy female volunteers
  • Age between 18 and 65
  • Written informed consent

排除标准

  • A history of any upper GI symptoms or GI surgery;
  • Psychological disorders;
  • Concomitant use of other medication or treatments except for oral contraceptives;
  • Use of medication altering esophageal or GI motility;
  • Pregnant or nursing women.

研究组 & 干预措施

Bitter

Experimental

A single intragastric administration of denatonium benzoate (1 µmol/kg)

干预措施: Denatonium Benzoate (Dietary Supplement)

Placebo

Placebo Comparator

A single intragastric administration of placebo (water)

干预措施: Water (Dietary Supplement)

结局指标

主要结局

Change in number of TLESRs

时间窗: 1 week

Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.

次要结局

  • Change in reflux(1 week)
  • Change in motility pattern(1 week)
  • Change in motilin concentration(1 week)
  • Change in symptoms(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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