To study the effect of low FODMAP diet on symptoms and quality of life in patients with Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Proportion of responders (symptom relief)
研究概览
简要总结
Functional Dyspepsia (FD) is a functional bowel disorder with significant global prevalence and contributes up to one third of gastroenterology outpatient appointments. It profoundly affects health-related quality of life likely due to its chronic nature and the co-existence of gastrointestinal (GI) and extra-intestinal symptoms. Currently, the gold standard for the diagnosis of FD is the Rome IV criteria. Rome IV subdivides FD into two sub groups, dependent on whether the symptoms are meal-related, the post prandial distress syndrome, or not, the epigastric pan syndrome. Currently, there are no reliable biomarkers to aid in the diagnosis of FD.
Current pathophysiological mechanisms implicated in the pathogenesis of FD include altered motility especially impaired accommodation and gastric emptying, visceral hypersensitivity, low-grade mucosal inflammation, dysbiosis of the gut microbiota, and abnormal central pain processing. There appears to be a degree of overlap with the mechanisms that are implicated in the pathogenesis of IBS. Furthermore, subjects with FD also have prominent “gas†related symptoms including bloating, belching, and distension. Subjects with FD also experience epigastric/abdominal pain and discomfort, and, in the prandial dis- tress syndrome sub-group, these symptoms are exclusively meal- related. This has led to researchers involved in FGID research to question whether FD and IBS are in fact two separate but related diseases, or simply one disease process with varying phenotypes
An incomplete understanding of the pathophysiology of IBS and its phenotypic heterogeneity has led to symptom-directed treatment approaches including PPI, prokinetics and anti-psychotics. However, less than one third of patients are satisfied with their current treatments. Dietary restriction of fermentable carbohydrates (low FODMAP diet) is now widely used in the management of IBS. These carbohydrates increase small intestinal water and colonic gas. Their dietary restriction has been investigated in few trials with up to 70% of patients reporting symptomatic benefit. However there is not even a single randomized study evaluating the effect of low FODMAP diet in FD patients, which motivated us to conduct this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age- 18-70 years 2.FD diagnosed according to ROME IV criteria.
- •3.Patients having inadequate relief of dyspepsia symptoms on current medications.
- •4.Upper GI Endoscopy negative for any organic cause for dyspepsia performed in the last 2 years.
- •5.H pylori infection negative by non-invasive testing or biopsy.
- •6.Celiac disease excluded by serology and/or biopsy.
排除标准
- •1.Presence of alarm symptoms like loss of appetite, loss of weight, dysphagia, anemia, new onset dyspepsia after 50 years age, hematemesis/malena, severe pain abdomen 2.Presence of a severe cardiac, liver, neurological or psychiatric disease 3.Predominant symptoms of another GI disease (e.g. IBS, GERD, gastroparesis, inflammatory bowel disease, Functional constipation/diarrhoea) that could explain the current symptoms.
- •4.Patients who are already on a diet excessively restricting certain nutrients before entering the study (e.g. low in FODMAPs, gluten-free, lactose free diet).
- •5.Prescription of bowel preparation for investigative procedures, antibiotic therapy, prebiotics or probiotics, and change of dyspepsia medication during the previous four weeks.
- •6.History of surgery involving upper GI tract 7.History of lactose/fructose intolerance, unless symptoms persist on a lactose/fructose free diet 8.Pregnant or lactating women.
结局指标
主要结局
1. Proportion of responders (symptom relief)
时间窗: 4 weeks
次要结局
- Improvement in quality of life