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临床试验/NCT01867151
NCT01867151Unknown不适用

Effetto Della Dieta Priva di Glutine in Soggetti Con BMS

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
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

入选标准

  • Primary BMS

排除标准

  • Celiac Disease
  • Psychiatric Disorders
  • intestinal autoimmune diseases
  • Ongoing cancer

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Pier Mannuccio Mannucci

Scientific Director

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (2)

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