Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
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
- 1
- 主要终点
- Identification of FODMAP intollerance in IBS subjects
研究概览
简要总结
The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.
详细描述
Study design:
For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled.
At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 4 weeks. At the end of the 4 weeks patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a gluten-containing diet for at least six months before enrollment
- •anti-transglutaminase antibodies (IgA and IgG) absence
- •normal serum IgA levels
- •prick and specific IgE tests for wheat allergy negative
排除标准
- •celiac disease
- •wheat allergy
- •chronic intestinal inflammatory diseases
- •psychiatric disorders
- •major abdominal surgery (in particular intestinal resections)
- •diabetes mellitus
- •previous anaphylactic episodes
- •gluten-free diet in the previous six months
- •pregnant or lactating women.
结局指标
主要结局
Identification of FODMAP intollerance in IBS subjects
时间窗: 4 weeks
To evaluate the FODMAP intolerance, the response to a low FODMAP diet will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.
Identification of NCGS in IBS subjects who responded to low FODMAPs diet
时间窗: 3 weeks
To evaluate the NCGS, the response to the gluten challenge will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.
次要结局
未报告次要终点
研究者
Michele Barone
Professor
University of Bari