Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet 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 randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS.
70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.
Questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index.
The primary endpoint to define clinical response will be evaluated over weeks 4-6 as >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 postprandial functional dyspepsia
- •Normal upper gastrointestinal endoscopy within last 3years
- •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 dietary interventions
- •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
研究组 & 干预措施
Traditional Dietary Advice
Recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre
干预措施: Dietary modifications (Other)
Low FODMAP diet
FODMAPs are fermentable carbohydrates that increase intestinal water and gas production that, in those with visceral hypersensitivity, induces gastrointestinal symptoms. The low FODMAP diet therefore excludes fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.
干预措施: Dietary modifications (Other)
结局指标
主要结局
Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)
时间窗: 6 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 0.5 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 average pre-treatment scores with the average score during weeks 4-6.
次要结局
- Changes in Hospital Anxiety and Depression scale(6 weeks)
- Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet(6 weeks)
- Changes in Napean Dyspepsia-related Quality of Life Index(6 weeks)
- Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale(6 weeks)
- Changes in Somatic Symptom reporting(6 weeks)
- Changes in nutritional intake(6 weeks)