Impact of an Online Service Offering Personalized Low-FODMAP Menus With Nutritional Support on Quality of Life and Control of Physical and Psychological Symptoms in People With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IBS-related quality of life
研究概览
简要总结
This study aimed to assess the impact of implementing the low Fermentable Oligo-, Di- and Monosaccharides, And Polyols (FODMAP) diet, through an online educational service platform, on the quality of life of patients living with irritable bowel syndrome (IBS). A prospective single-group intervention pilot study involving patients with IBS from two hospitals was conducted. Participants followed the low FODMAP diet using a web-based platform for 6 months. The IBS quality of life questionnaire (IBS-QoL), the IBS symptom severity scoring system (IBS-SSS) and the State-Trait Anxiety Inventory Form Y (STAI) were completed at baseline, after the restriction phase and after reintroduction phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of IBS according to the Rome IV criteria by a gastroenterologist within the past three months
- •understand French
- •have an Internet access and a Facebook© account with a self-reported familiarity to use them
排除标准
- •patients suffering from a known eating or mental health disorder
- •body mass index under 18.5 kg/m2
- •type 1 or 2 diabetes
- •pregnancy
- •other chronic gastrointestinal diseases, except gastroesophageal reflux
结局指标
主要结局
IBS-related quality of life
时间窗: From enrollment to the end of intervention at 6 months.
The primary outcome was the change in QoL from baseline to the end of study, assessed by the validated IBS-QoL questionnaire. This questionnaire assesses 8 domains, namely dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual concerns and relationships, from which a computed score is drawn. This score, ranging from 0 to 100, was developed to assess the self-reported QoL in IBS, a higher score indicating a better QoL.
次要结局
- Severity of IBS symptoms(From enrollment to the end of intervention at 6 months.)
- State and trait anxiety(From enrollement to the end of intervention at 6 months.)