Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Patient's ability to correctly identify the phase with gluten
研究概览
简要总结
The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adherence to gluten free diet without medical need
- •Negative Celiac Disease related serology (while on gluten containing diet)
- •Normal villous structure at duodenal biopsy (while on gluten containing diet)
排除标准
- •Diagnosis of Celiac Disease
- •Diagnosis of Wheat Allergy
- •Diagnosis of organic gastrointestinal disease
- •Severe concomitant disease
结局指标
主要结局
Patient's ability to correctly identify the phase with gluten
时间窗: Time (days) 35
* time 0: start of first challenge (phase A, either with gluten or gluten free flour) * time 10: end of phase A and start of wash-out period * time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) * time 35: end of phase B
次要结局
- Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary(From Time 0 (days) to 10 and from 25 to 35)
- Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG(Time (days) 0, 10, 25, 35)
- Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten(Time (days) 0,10, 25, 35)
- Change in Fatigue Visual Scale(Time (days) 0, 10, 25, 35)
研究者
Alberto Lanzini, MD PhD
Associate Professor of Gastroenterology
Università degli Studi di Brescia