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临床试验/NCT04401956
NCT04401956已完成不适用

Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread

University of Hohenheim2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change of IBS-SSS Total score

研究概览

简要总结

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.

详细描述

Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).

It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.

For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Age ≥18 ≤70 years
  • Signed declaration of consent
  • Willingness to adhere to the prescribed diet for the duration of the study
  • Subjective bread wheat intolerance
  • No known spelled intolerance
  • No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
  • No participation in another clinical trial (current or within the past 30 days)
  • Gluten-containing diet at least 6 weeks before the start of the study

排除标准

  • Taking intestinal therapeutics, antibiotics, immunosuppressants or similar
  • Pregnancy / lactation
  • Relevant violations of the nutritional protocol
  • Occurrence of relevant diseases (possibly individual decision)
  • Revocation of consent
  • Accommodation in a clinic or similar facility based on an official or judicial order

结局指标

主要结局

Change of IBS-SSS Total score

时间窗: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)

IBS-SSS Total score will be collected with a questionnaire

次要结局

  • Extraintestinal Symptoms(Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).))
  • Blood and fecal markers(Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)

研究者

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

Stephan C. Bischoff, MD, Professor

Professor Dr. med.

University of Hohenheim

研究点 (2)

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