Effetto Della Dieta Priva di Glutine in Soggetti Con BMS
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- oral pain
研究概览
简要总结
Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary BMS
排除标准
- •Celiac Disease
- •Psychiatric Disorders
- •intestinal autoimmune diseases
- •Ongoing cancer
研究组 & 干预措施
Gluten free diet
BMS patients following a GFD
干预措施: Gluten Free Diet (Dietary Supplement)
Normal Diet
Patients with BMS maintaing a normal diet
干预措施: Normal Diet (Dietary Supplement)
结局指标
主要结局
oral pain
时间窗: 28 days
oral pain will be evaluated by means of visual analogue scales
次要结局
- Quality of Life(28 days)
研究者
Prof. Pier Mannuccio Mannucci
Scientific Director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico