跳至主要内容
临床试验/NCT06063044
NCT06063044已完成不适用

Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
407
试验地点
1
主要终点
FS-IgG4

研究概览

简要总结

Allergic diseases in children are major public health concerns due to their widespread and rising prevalence. The most classic pathway to trigger allergy is type I allergy mediated by immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in allergic diseases is still worth exploring.we have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total IgE, HDM IgE, FS-IgE and FS-IgG4. Meanwhile, investigators screened out patients who were treated with FS-IgG4-guided elimination diets with/without probiotics for more than 3 months to clarify the role of FS-IgG4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment.

详细描述

Allergic diseases in children are major public health concerns due to their widespread and rising prevalence. And management of allergic diseases beyond medication, such as food management is also very important. The most classic pathway to trigger allergy is type I allergy mediated by immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in allergic diseases is still worth exploring.In present study, investigators have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total IgE, house dust mite (HDM) IgE, FS-IgE and FS-IgG4. Meanwhile, investigators screened out patients who were treated with FS-IgG4-guided diet elimination with/without probiotics for more than 3 months to clarify the role of FS-IgG4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment. This retrospective study was conducted to clarify the clinical relevance of food-specific IgG4 in allergic diseases and the effect of dietary avoidance on clinical symptoms, thus making a breakthrough in the diagnosis and treatment of childhood allergies.

研究设计

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

入排标准

年龄范围
8 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of allergic rhinitis.
  • Clinical diagnosis of asthma.
  • Clinical diagnosis of conjunctivitis.
  • Clinical diagnosis of urticaria.
  • Clinical diagnosis of atopic dermatitis.
  • Total IgE,FS-IgE, HDM-IgE and FS-IgG4 must be tested.

排除标准

  • · Autoimmune diseases.

结局指标

主要结局

FS-IgG4

时间窗: 2018.1-2020.12

The positive rates of FS-IgG4 in respiratory, cutaneous and multi-system groups were evaluated.

The difference of total-IgE and FS-IgG4 positive rates among the three groups

时间窗: 2018.1-2020.12

Chi-square test was used to compare total-IgE (+) FS-IgG4 (+), total-IgE (+) FS-IgG4 (-), total-IgE (-) FS-IgG4 (+) and total-IgE (-) FS-IgG4 (-) among the three groups.

HDM-IgE

时间窗: 2018.1-2020.12

The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.

Comparison of FS-IgG4 positive rates among the three groups

时间窗: 2018.1-2020.12

The differences of 10 food-specific IgG4 antibodies (including eggs, milk, cod, beef, chicken, wheat, prawns, crab, mushrooms) in respiratory, skin and multi-system groups were evaluated.

Age of participants

时间窗: 2018.1-2020.12

Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.

Family history of allergies of the participants

时间窗: 2018.1-2020.12

Family history of allergies of the participants were evaluated in the respiratory, dermatological and multisystemic groups.

FS-IgE

时间窗: 2018.1-2020.12

The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated.

The difference of FS-IgE and FS-IgG4 positive rates among the three groups

时间窗: 2018.1-2020.12

Chi-square test was used to compare FS-IgE (+) FS-IgG4 (+), FS-IgE (+) FS-IgG4 (-), FS-IgE (-) FS-IgG4 (+) and FS-IgE (-) FS-IgG4 (-) among the three groups.

birth mode of participants

时间窗: 2018.1-2020.12

Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.

total IgE

时间窗: 2018.1-2020.12

The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.

Gender ratio of participants

时间窗: 2018.1-2020.12

Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验