Randomised Trial of Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of clinical responders between traditional dietary advice vs. reassurance alone based on the leuven postprandial distress scale (LPDS)
研究概览
简要总结
Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.
The investigators will perform a single-centre randomised trial evaluating traditional dietary advice (TDA) in PDS.
50 patients with PDS will be randomly assigned to a leaflet explaining reassurance-alone +/- TDA. The reassurance-alone group will be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia. The TDA group will receive the same information but also be recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre.
Questionnaires are to be completed during the 4-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Napean Dyspepsia Quality of Life Index.
The primary endpoint(s) to define clinical response will be evaluated over weeks 3-4 as, i) ≥50% adequate relief of dyspeptic symptoms, and ii) >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfil Rome IV symptoms criteria for functional dyspepsia
- •Normal upper gastrointestinal endoscopy within last 3 years
- •Online access
- •English literate
排除标准
- •Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)
- •Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
- •Documented H.pylori in the last 3 months
- •History of eating disorders
- •Body mass index <20
- •Current use of opioids or anti-inflammatory drugs
- •Severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations
- •Diabetes mellitus
- •Scleroderma
- •Memory impairment
- •Current dietary interventions
结局指标
主要结局
Proportion of clinical responders between traditional dietary advice vs. reassurance alone based on the leuven postprandial distress scale (LPDS)
时间窗: 4 weeks
The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.7 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing averaged pre-treatment scores with the average score during the weeks 3-4.
Proportion of clinical responders between traditional dietary advice vs. reassurance alone
时间窗: 4 weeks
Self-reported adequate relief of dyspeptic symptoms as a binary answer (yes or no). A responder will be defined if ≥50% adequate relief of dyspeptic symptoms during weeks 3-4
次要结局
- Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale(4 weeks)
- Changes in Hospital Anxiety and Depression scale(4 weeks)
- Changes in Somatic Symptom reporting(4 weeks)
- Changes in Napean Dyspepsia-related Quality of Life Index(4 weeks)