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临床试验/NCT04219813
NCT04219813招募中不适用

Urinary Gluten Detection in Patients with Non-celiac Gluten/Wheat Sensitivity

University of Palermo4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
4
主要终点
Adherence to GFD of NCGS/NCWS patients

研究概览

简要总结

Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome [IBS]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (Gluten Immunogenic Peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS/NCWS patients, on GFD, eat, even accidentally, gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms/signs appearing and/or social activities (e.g. meal in a restaurant). The aims of the present study are: 1) to test, in patients with NCGS/NCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.

详细描述

Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome [IBS]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. Recent data suggest that NCGS affect up to 3-6% of the general population, a higher prevalence than that reported for CD. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced. GDF is very difficult and onerous from a social (presence of gluten in many industrial food products and "contamination", both domestic and extra-domestic), psychological (e.g. for adolescents, exclusion from the "peer group", with difficulty in accepting the diagnosis) and economic point of view. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (gluten immunogenic peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS/NCWS patients, on GFD, eat even accidentally gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms/signs appearing and/or social activities (e.g. meal in a restaurant). The other one involves collecting a stool sample and allows to identify the gluten taken in the previous week, but it requires a laboratory, specifically equipped. To date, there are no observational studies that indicate the performance of the test in patients with NCGS/NCWS. The aims of the present study are: 1) to test, in patients with NCGS/NCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

入选标准

  • patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD).

排除标准

  • celiac patients or those suffering from IgE-mediated gluten/wheat allergy.

结局指标

主要结局

Adherence to GFD of NCGS/NCWS patients

时间窗: 24 months

The researchers will evaluate the adherence to Gluten-Free Diet (GFD) of NCGS/NCWS patients on GFD by the absence/presence of gluten immunogenic peptides (GIP) in their urine samples.

次要结局

  • Gastrointestinal and extraintestinal symptoms/signs reappearance(24 months)

研究者

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

Pasquale Mansueto

Clinical Professor

University of Palermo

研究点 (4)

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