Effect of a Gluten Free Diet in Patients With IBS
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
- Determination of inflammatory Stimulation of monocytes after gluten exposure
研究概览
简要总结
Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.
详细描述
Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS.
In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •healthy controls without gastrointestinal Symptoms
- •patients with irritable bowel Syndrome (Rome IV criteria)
排除标准
- •inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
- •celiac disease
- •wheat allergy
- •pregnancy
结局指标
主要结局
Determination of inflammatory Stimulation of monocytes after gluten exposure
时间窗: six weeks
Real-time PCR is used to determine the fold Change of gene expression of Interleukins IL-1ß and IL-6 after 24 hours of stimulation of peripheral monocytes with gluten Fragments (0,5 mg/ml)
Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD)
时间窗: six weeks
Detection of differences in relative gene Expression of inflammatory parameters (IL-1ß and IL-6) between patients with IBD and healthy controls
次要结局
- Determination of a subgroup of Patients with NCGS in IBS cohorte(six weeks)
- Effect of a gluten free diet on improvement of gastrointestinal symptoms(six weeks)
- Effect of the gluten free diet on Quality of life(six weeks)
研究者
yurdagül zopf
Professor
University of Erlangen-Nürnberg Medical School