NCT07196735招募中不适用
Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in phase angle between healthy patients and patients with FD
研究概览
简要总结
The primary objective of this study is to compare the BIA parameters, including Phase Angle, Fat Free Mass and Fat Mass, between women with functional dyspepsia and healthy women. All woman will undergo a bio-electrical impedance monitoring for this.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 - 75 years
- •Fulfilling the ROME IV criteria for functional dyspepsia (for FD patients)
- •FD unexplained by upper GI endoscopy during the past 12 months (mild gastritis allowed) (for FD patients).
排除标准
- •Clinical suspicion of an organic disorder different from FD (patients can be included when this disorder had been excluded);
- •Abnormality on upper GI endoscopy other than mild gastritis (for FD patients).
- •Known reflux oesophagitis Los Angeles grade C or D, known Barrett oesophagus, peptic stricture.
- •H pylori infection, unless treated at least 6 months before;
- •Known inflammatory bowel disorder;
- •Known major intestinal motility disorder;
- •Alcohol (defined as more than 14 U per week) or other substance abuse;
- •Active psychiatric disorder;
- •Known systemic or auto-immune disorder with implication for the GI system;
- •Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);
- •Any prior diagnosis of cancer other than basocellular carcinoma;
- •Current chemotherapy;
- •History of gastro-enteritis in the past 12 weeks;
- •Dietary supplements unless taken at a stable dose for more than 12 weeks;
- •Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);
- •Treatment with PPI's during the past 8 weeks
- •Pregnancy.
结局指标
主要结局
Difference in phase angle between healthy patients and patients with FD
时间窗: from signing of the ICF till end of study (on average 1 week)
Difference in fat mass between healthy patients and patients with FD
时间窗: from signing of the ICF till end of study (on average 1 week)
Difference in fat free mass between healthy patients and patients with FD
时间窗: from signing of the ICF till end of study (on average 1 week)
次要结局
未报告次要终点
研究者
研究点 (1)
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