Effect of a Low- Fermentable-Oligo-Di-Monosaccharides and Polyols (FODMAPs) Diet Group Intervention on IBS Symptoms and Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change in IBS Symptom Severity Scores (IBS-SSS)
研究概览
简要总结
Irritable bowel disease (IBS) is a functional gastrointestinal disorder that affects 10% of the population. Comorbidities are common and fatigue is the most common extraintestinal complaint in IBS patients. There are no cure for the disease but there are nutrition treatments that can relieve symptoms. The main goal of this randomized controlled trial is to test the hypothesis that low-Fermentable- oligo-di- monosaccharides and polyols (FODMAPs) diet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.
详细描述
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by stomach pain at least one day a week accompanied by change in stool frequency or appearance. Prevalence of IBS is about 10 % of the population worldwide and more common in women. IBS is divided into different subclasses: diarrhea predominant, (IBS-D), predominant constipation, (IBS-C), mixed bowel habits, (IBS-M). Comorbidities are common and fatigue is the most common extraintestinal complaint among the patients. Patients has severely reduced quality of life, reduced work capacity and the cost are substantial for the patients and the society. IBS can´t be cured but the symptoms can be relieved by pharmacological as well as non-pharmacological treatment as psychological- and nutritional treatment. The main goal of this randomized controlled trial is to test the hypothesis that low FODMAPdiet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.
FODMAPs is an acronym for Fermentable-Oligo-Di-Monosaccharides and Polyols. FODMAPs are carbohydrates that can't be absorbed/splinted in the large intestine and they ferment rapidly and exacerbate gastrointestinal symptoms as flatulence, pain, bloating and loose stools. In total 120 patients with IBS-D and IBS-M will be randomized to immediate treatment start or delayed treatment start. The treatment will be performed in clinical setting, led by a dietitian and in group format including 12 patients in each group. The intervention time is 12 weeks with 5 group visits at a gastroenterology unit. The low-FODMAP treatment is divided into three steps: elimination of FODMAPs, re-introduction and personalization of the diet. Compliance to the diet will be measured by monitoring the FODMAP intake from three day food diaries and a compliance form. Questionnaires will be self reported in a web based application. Food diaries and the stomach diary will be filled out at baseline, at week 5, 12 and 6, 12 and 24 months post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in IBS Symptom Severity Scores (IBS-SSS)
时间窗: Change in baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.
Visual Analogues Scale (VAS-scale), composite score measuring bloating, bowel habits, satisfaction with with bowel habits and how IBS impact on QOL. Minimum score 0 and maximum score 500, higher scores indicates more severe disease
次要结局
- Change in Multidimensional Fatigue Inventory (MFI-20)(Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.)
- Change in Visceral sensitivity index (VSI)(Baseline week 0 and after intervention at 12 weeks and at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.)
- Change in the gastrointestinal symptom rating scale (GSRS-IBS)(Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.)
- Change in World Health Organisation (WHO) Disability Assessment Schedule (WHODAS 2.0)(Baseline week 0 and at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.)
- Change in Sickness behaviour (SQ)(Baseline week 0 after intervention at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.)
研究者
Perjohan Lindfors
Operations Manager and Chief Physician
Karolinska Institutet