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临床试验/NCT05259826
NCT05259826招募中不适用

Improving the Diagnosis of Food Allergy and Food Intolerance by Determining Mucosal IgE and Inflammatory Markers and Validating With Intestinal in Vitro Organoids

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
115
试验地点
2
主要终点
Determination of mucosal IgE to identify patients with gastrointestinal food allergy

研究概览

简要总结

Aim of the study is to improve the diagnosis of food allergy and hypersensitivity. Intestinal homogenates will be used to determine total IgE, specific IgE, tryptase, histamine and inflammation parameters (IFNgamma, TNFalpha). These data will be correlated with serum values and disease status. In addition, organoids from duodenal tissue will be isolated and cultured in vitro and stimulated with the major food allergens. The gene and protein expression will be checked to identify relevant biomarkers.

详细描述

Food intolerances (FI) show an increasing prevalence and represent a particular challenge in clinical practice. The symptoms of a predominantly gastrointestinally mediated food allergy (FA) are similar to the symptoms of other FI (e.g. carbohydrate malabsorption, gluten sensitivity, histamine intolerance, irritable bowel syndrome), so that diagnosis is difficult and often delayed.

Well-evaluated methods for the clarification of an allergic disease are serological screening (IgE against food products or other cross-reacting allergens) and skin prick tests. However, these methodes have their limitations in the diagnosis of seronegative or mainly gastrointestinal-mediated FI. Patients often associate the consumption of certain foods with the clinical symptoms, which often leads to strict self-imposed elimination diets, but rarely to the correct identification of the triggering food.

In a pilot study, the investigators showed that patients with gastrointestinal FI have elevated mucosal IgE levels and TNF using homogenates from intestinal biopsies. Another patient subgroup could be identified that showed low allergic parameters (low mucosal IgE, low TNF) but high mucosal interferon levels, indicating a non-specific inflammation.

In this study, mucosal IgE, tryptase, histamine, IL4, and inflammatory parameters (e.g. TNF, IFN) from different areas of the gastrointestinal tract will be determined in a larger collective. Furthermore, organoids are cultured in vitro from duodenal tissue samples, incubated with blood cells and stimulated with food allergens. The titres of specific IgE from the mucosal homogenates will be correlated with serum levels and organoid stimulation results to identify relevant biomarkers. Microbiome and metabolome analyses will provide information about the intestinal flora in FI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent
  • patients with suspected food allergy or hypersensitivity
  • healthy controls with indications for endoscopic diagnostics, e.g. tumour history within the family, exclusion of gastritis

排除标准

  • pregnant person

结局指标

主要结局

Determination of mucosal IgE to identify patients with gastrointestinal food allergy

时间窗: 3 years

Homogenates of mucosal biopsies will be checked for IgE levels

次要结局

  • Correlation of mucosal IgE and inflammatory parameters with data from organoids(3 years)
  • Identification of patients with food hypersensitivity(3 years)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

yurdagül zopf

Professor Dr.

University of Erlangen-Nürnberg Medical School

研究点 (2)

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