Beneficial Effects of a Low FODMAPs Diet in Different Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Improvement of IBS-SSS after 3 months
研究概览
简要总结
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.
详细描述
Recurrent gastrointestinal symptoms (bloating, constipation, abdominal pain, diarrhea and flatulence) often interfere with patients' quality of life (QoL) and daily activities. These symptoms have been noted in various diseases such as irritable bowel syndrome (IBS), celiac disease (CD) and inflammatory bowel diseases (IBD). IBS is the most common diagnosis made by gastroenterologists and affects up to 15% of the population. About 60% of patients with IBS claims that certain foods can exacerbate their symptoms, so pharmacological treatment is often accompanied by dietary measures. Very recently, a diet for the management of functional symptoms associated with IBS has been developed: the low FODMAPs diet. FODMAPs (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) is a collective term that indicates a family of poorly absorbed short-chain carbohydrates. The low FODMAPs diet is a relatively novel area of interest and the majority of studies have been performed in patients with IBS; most of them showed that limiting FODMAPs led to an improvement of intestinal symptoms. Patients with Crohn's disease (CrD) and ulcerative colitis (UC) often experience symptoms related to concomitant functional disease, such as bloating, abdominal pain and flatulence, in the absence of active inflammation. These symptoms are less likely to respond to the common anti-inflammatory drugs and it is important to recognize them, in order to avoid inappropriate therapy and improve QoL. In effect, the cause of these symptoms is related to altered function of the gut and the enteric nervous system, rather than to the inflammatory activity of disease. In these patients, carbohydrate malabsorption has been considered a candidate mechanism by which the diet can induce gut symptoms: lactose and fructose malabsorption has been recognized as a potential cause of symptoms due to the high osmotic activity and fermentability of malabsorbed lactose.
The management of this condition could benefit of a dietary intervention, but data regarding the effect of a low FODMAPs diet in IBD are limited.
Also in coeliac patients, despite a lifelong GFD, some abdominal symptoms such as flatulence, bloating, diarrhea and abdominal pain can persist. However data regarding the effect of a low FODMAPs diet in these subjects are still scarce.
On the basis of these considerations, the aim of this study was to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission.
Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaires on quality of life and symptoms (IBS-SSS and SF-36) (T0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS patients
- •IBD patients in remission
- •Coeliac patients on gluten free diet
排除标准
- •Active IBD
- •Coeliac patients non compliant to gluten free diet
结局指标
主要结局
Improvement of IBS-SSS after 3 months
时间窗: 1 month and 3 months
to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission. Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaire on quality of life and symptoms (IBS-SSS). The questionnaire was re-administered after 1 month and 3 months of low FODMAPs diet.
次要结局
- Improvement of SF-36 after 3 months(1 month and 3 months)
研究者
Fabiana Castiglione
Associate Professor
Federico II University
