NCT04712617已完成不适用
Sex and Gender Difference in Overlap Syndrome of Functional Gastrointestinal Disorder and the Effect of Genetic Polymorphism in South Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 主要终点
- Hospital anxiety and depression scale (HADS)
研究概览
简要总结
- To analyze the prevalence of overlap syndromes among NERD or RH, FD, and IBS patients, and to identify and to compare the differences in their characteristics and symptoms, and to determine their risk factors.
- To identify the differences in clinical features according to sex and gender.
- To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No organic diseases in routine laboratory tests, abdominal imaging, esophagogastroscopy, and colonoscopy
- •NERD or reflux hypersensitivity (RH): typical heartburn occurring at least once a week without visible esophageal mucosal break detected by endoscopy
- •FD or IBS: based on the Rome III criteria
- •Control group
- •Subjects who underwent GI evaluations as part of health check-up or for other problems, such as mild abdominal discomfort or pain for a relatively short period of time, but had no organic problems during GI endoscopy
排除标准
- •history of GI surgery except appendectomy
- •inflammatory bowel disease
- •any malignancy, or systemic diseases requiring chronic medication except for hypertension and diabetes mellitus
- •pregnant or lactating women
- •hepatic, biliary, or psychiatric disorders requiring medication.
结局指标
主要结局
Hospital anxiety and depression scale (HADS)
时间窗: per 16 years
by HADS questionnaire
Symptom severity score (5 Likert scale, from 0 to 4)
时间窗: per 16 years
FGID symptom severity score score by K-BDQ
Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene
时间窗: per 16 years
次要结局
- Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients(per 16 years)
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital
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