The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Improvement on gastrointestinal symptoms
研究概览
简要总结
Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).
Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients.
The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status.
Additional purposes include investigating effects gluten free diet may have on other parameters:
- Improvement of mood
- Quality of life and general well-being
- Changes in gut microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients
- •IBS diagnosis (Rome III)
- •Willingness to participate
排除标准
- •history of any organic disease including celiac disease
- •Immune deficiency
- •Major abdominal surgery
- •Use of immunosuppressants, glucocorticosteroids or opioids
- •Use of antibiotics in the last 3 months
研究组 & 干预措施
Gluten free diet
Single arm
干预措施: Gluten free diet (Other)
结局指标
主要结局
Improvement on gastrointestinal symptoms
时间窗: 4 weeks
Decrease \>2 points IBS Birmingham score
次要结局
- Improvement somatization(4 weeks)
- Changes in gut microbiota(4 weeks)
- Improvement anxiety and/or depression(4 weeks)
- Improvement quality of life and well-being(4 weeks)
- Normalization of gastrointestinal transit(4 weeks)