Role of low FODMAP diet in patients with Irritable bowel syndrome (IBS) : a randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in IBS-SSS (symptom severity score)
研究概览
简要总结
Irritable bowel syndrome (IBS) is a functional bowel disorder with a global prevalence of 11% and contributes up to 60% 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. An incomplete understanding of the pathophysiology of IBS and its phenotypic heterogeneity has led to symptom-directed treatment approaches including antispasmodics and anti-diarrheals. However, less than 40% of patients are satisfied with their current treatments. Dietary restriction of fermentable carbohydrates (fermentable oligosaccharides, monosaccharides, disaccharides and polyols- FODMAP) is now widely used in the management of IBSD. 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 on Indian population evaluating effect of low FODMAP diet in IBSD 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.IBS-D diagnosed according to ROME IV criteria.
- •2.Age- 18-70 years 3.Currently having medium-severe symptoms [as indicated by IBS Symptom Severity Score (IBS-SSS) ≥17.5].
排除标准
- •1.Presence of a severe cardiac, liver, neurological or psychiatric disease 2.Presence of another GI disease than IBS (e.g. inflammatory bowel disease, celiac disease) that could explain the current symptoms.
- •3.Patients with IBS –Constipation predominant 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 to IBS medication during the previous four weeks.
结局指标
主要结局
Change in IBS-SSS (symptom severity score)
时间窗: 4 weeks
次要结局
- 1. Change in stool frequency(2. Change in nutrient intake)
