Glutox Trial. Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity: a Double Blind Crossover Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Pain Scores on the Visual Analogue Scales
研究概览
简要总结
Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.
详细描述
The proposed study has been designed to be a randomised double-blind multicenter clinical trial with crossover. The Coordinating Center will be the "Centro per la Prevenzione e la Diagnosi della Malattia Celiaca", Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano. Secondary enrollment centers will be Italian Gastroenterology Units with outpatient services. Enrollment criteria will be diagnosis of irritable bowel syndrome (IBS) or functional dyspepsia. Patients with other functional gastrointestinal disorders will be included in the group "Functional non specific gastrointestinal symptoms".
After they give their written informed consent, patients will undergo the diagnostic work-up recommended in case of suspected irritable bowel symptoms/functional dyspepsia and aimed at the exclusion of CD or allergy to alimentary antigens by means of serological testing (anti transglutaminase antibodies) or skin tests, or other gastrointestinal diseases. Endoscopic, histologic and/or imaging exams together with supplemental blood tests will be prescribed on individual cases and according with the international guidelines.
Enrolled subjects will be asked to fill
- a checklist for the evaluation of the psychological profile (SCL90 questionnaire, with the particular aim of evaluating levels of anxiety, depression and somatisation);
- a questionnaire about the perceived level of physical and mental health (SF36 questionnaire);
- Ten centimeters long visual analogue scales (VAS) on the level of satisfaction with their health status and on the intensity of the single symptoms.
At the end of the present phase patients will start a GFD for the subsequent three weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)
排除标准
- •Celiac disease
- •Alimentary allergies
- •Inflammatory bowel disease
- •Major abdominal surgery
- •Psychiatric disorders
- •Neoplasia
研究组 & 干预措施
suspected NC gluten sensitive
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
干预措施: Placebo (Dietary Supplement)
suspected NC gluten sensitive subjects
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
干预措施: gluten (Dietary Supplement)
suspected NC gluten sensitive subjects
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
干预措施: Placebo (Dietary Supplement)
suspected NC gluten sensitive
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
干预措施: gluten (Dietary Supplement)
结局指标
主要结局
Pain Scores on the Visual Analogue Scales
时间窗: 28 days
Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales
次要结局
- Quality of Life(28 days)
研究者
Luca Elli
researcher
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico