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临床试验/CTRI/2019/02/017450
CTRI/2019/02/017450已完成不适用

Role of low FODMAP diet in patients with Irritable bowel syndrome (IBS) : a randomized trial

Department of Gastroenterology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月15日最近更新:

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)

研究者

申办方类型
Private medical college

研究点 (1)

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