NL-OMON48356已完成不适用
*The Experience Sampling Method (ESM): Validation of a newly developed real-time Patient-Reported Outcome Measure (PROM) and its Evaluation of triggers for Functional Dyspepsia* - MEASuRE-D
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for patients with functional dyspepsia
- •* A diagnosis of functional dyspepsia according to Rome IV criteria (2):
- •- One or more of the following:
- •- Bothersome postprandial fullness
- •- Bothersome early satiation
- •- Bothersome epigastric pain
- •- Bothersome epigastric burning
- •- No evidence of structural disease (including at upper endoscopy) that is
- •likely to explain the symptoms.
- •- Criteria fulfilled for the last 3 months with symptom onset at least 6
- •months before diagnosis.
- •* Age between 18 and 75 years;
- •* Ability to understand and speak the Dutch language;
- •* Ability to understand how to utilize the ESM tool.
- •Inclusion criteria for healthy volunteers
- •* Age between 18 and 75 years
- •* Ability to understand and speak the Dutch language
- •* Ability to understand how to utilize the ESM tool.
排除标准
- •Exclusion criteria for patients with functional dyspepsia
- •* Any organic explanation for the gastrointestinal complaints;
- •* Initiation of regularly used medication from one month before inclusion until
- •the end of study participation;
- •* A history of upper digestive surgery influencing end points
- •* A history of radiation therapy of the abdomen
- •* Pregnancy
- •Exclusion criteria for healthy volunteers
- •* Current diagnosis of any gastrointestinal disorder
- •* Current gastrointestinal symptoms suiting the ROME IV criteria for FD
- •* Initiation of regularly used medication from one month before inclusion until
- •the end of study participation
- •* Pregnancy
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