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临床试验/NCT02823522
NCT02823522招募中不适用

Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? A Follow-up Study

University of Palermo4 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2016年7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
280
试验地点
4
主要终点
How many patients were still following a gluten-free or a wheat-free diet

研究概览

简要总结

Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. While it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.

详细描述

Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD) diagnosis by negative CD-specific serum antibodies and absence of intestinal villi atrophy, and excluding IgE-mediated wheat allergy, by negative serum specific IgE and/or skin prick test with wheat antigens. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Obviously, this a cumbersome and time-consuming procedure which has been used in few studies.

Despite an increasing percentage of the general population define themselves as "gluten-sensitive", and by the year 2017 the market of the gluten-free products will be worth 6.6 billion of dollars, doubts persist about many aspects of NCGS. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. Furthermore, while it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS.

On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011).

The present prospective study aimed to evaluate the persistence of the NCWS condition in that cohort and, consequently, the researchers estimated : A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Patients previously diagnosed with NCWS by DBPC challenge.

排除标准

  • The 22 patients, included in the previous study, who tested positives for anti-endomysial antibodies (EmA) in the culture medium of the duodenal biopsies, even if the villi/crypts ratio in the duodenal mucosa was normal, were excluded from the present study.

结局指标

主要结局

How many patients were still following a gluten-free or a wheat-free diet

时间窗: Between July and November 2016

A structured questionnaire was administered to evaluate how many patients were still following a gluten-free diet (GFD) and how many a wheat-free diet.

次要结局

  • Evaluation of the effect of the GFD on IBS symptoms(Between July and November 2016)
  • Evaluation of the severity of the IBS condition(Between July and November 2016)
  • Re-evaluation of the NCWS condition by DBPC-Wheat challenge(Between July and November 2016)

研究者

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

Pasquale Mansueto

MD

University of Palermo

研究点 (4)

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