Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
研究概览
简要总结
Background:
Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter pylori infection, etc. However, few reported the association of genetic contribution to the development of FD and mood disorder.
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims:
- To evaluate genetic factors on development of functional dyspepsia & common mood disorders
- To evaluate genetic factors on the severity of function dyspepsia & mood disorders
- To develop a diagnostic test for classification of functional dyspepsia by plasma ghrelin and serotonin expression
- To collect sleep data for future use
- To save blood sample for future retrospective diagnostic or genetic examination
Study design:
Case-control cross sectional study
Number of subjects:
Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls + 300 FDR)
Patient population:
Functional dyspepsia patients age 18-60
Duration of study:
1 May 2012 - 30 April 2013
Primary variable(s):
Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression
Secondary variable(s):
FD global symptom assessment and symptom scores
Number of visits: 1
Hypotheses:
- Shared genetic factors contribute to the development of FD and common psychological disorders
- FD patients contribute to suppression of plasma ghrelin and serotonin expression compared to healthy controls
详细描述
Methods:
All subjects will participate in (1) Demographic assessment, (2) Questionnaires administration and (3) Blood sample collection. The three steps must be completed within 2 weeks.
- Demographic assessment
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight
- Smoke and drink habit
- Comorbidity and medical history
- Questionnaires administration
- A combined functional gastrointestinal (GI) symptom questionnaire (FGISQ) based on recall of the past 7 days will be used for assessment all GI symptoms including regurgitation, heartburn, epigastric pain, postprandial fullness, abdominal pain, diarrhea, constipation etc. All questions use a 4-point (0-3) Likert scale.
- FGI Screening Questionnaire (v.3, 20101011) for screening of functional gastrointestinal disorder according to Rome III criteria. The questionnaire incorporate a GERD diagnostic questionnaire GERDQ (Chinese version)
- Hospital Anxiety and Depression Scale (HADS) for a self administered scale for seven covering depression and seven covering anxiety.
- Psychological disorder: Patient Health Questionnaire (PHQ) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.
- The Epworth Sleepiness Scale, Pittsburgh sleep quality index, and General Sleep Quality Questionnaire to collect sleep data for future use.
- Blood sample collection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subject
- •Age 18-60
- •Provision of written consent
- •Additional to FD patient
- •Symptoms fulfilling Rome III criteria of functional dyspepsia
- •Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding
排除标准
- •All subject
- •History of cancer
- •Diabetes mellitus
- •History of gastric surgery
- •Acid suppressants or medications that affect motility in past 4 weeks
- •Organic disease as cause of dyspepsia (for subjects with dyspeptic symptom)
- •Additional to healthy volunteer
- •Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain, bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks
- •Additional to FD patient
- •Frequent (once or more per week) acid reflux or heartburn symptoms
- •Helicobacter pylori (Hp) infection
结局指标
主要结局
Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
时间窗: up to 48 months
Differences of genetic polymorphism in targeted genes in patients with FD and mood
次要结局
- Diagnosis of psychiatric disorder with PHQ and HADS(up to 48 months)
- Differences of plasma ghrelin and serotonin expression in FD patients and study controls.(up to 48 months)
- Symptom scores(up to 48 months)
研究者
Justin Che-Yuen Wu
Professor
Chinese University of Hong Kong