Influence of the Immunosystem in Non-celiac Glutensensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Determination of clinical symptomatics
研究概览
简要总结
Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.
详细描述
Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat specific IgE are done.
After exclusion of celiac disease and wheat allergy patients are considered as patients with NCGS.
Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet.
At the beginning and the end of each diet the participants fill in questionnaires concerning Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB), gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart). Furthermore, stool samples are selected at each time point to determine the microbial pattern.
NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •patients with glutensensitivity
排除标准
- •patients with glutensensitivity but without celiac disease or wheat allergy
结局指标
主要结局
Determination of clinical symptomatics
时间窗: 2 weeks
Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
Determination of psychological symptoms
时间窗: 2 weeks
Improvement of well-being by questionnaire psychological General well-being index
次要结局
- Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol(2 weeks)
- Intraepithelial lymphocytes(4 weeks)
- microbiome(2 weeks)
- Goblet cells(4 weeks)
研究者
yurdagül zopf
Prof. Dr.
University of Erlangen-Nürnberg Medical School