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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06063044
Other study ID # No. 2022-0380
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information

Verified date June 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 407
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 8 Months to 14 Years
Eligibility Inclusion Criteria: 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. Exclusion Criteria: ยท Autoimmune diseases.

Study Design


Locations

Country Name City State
China Second Affiliated Hospital,School of Medicine,Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age of participants Age of participants were evaluated in the respiratory, dermatological and multisystemic groups. 2018.1-2020.12
Primary Gender ratio of participants Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups. 2018.1-2020.12
Primary birth mode of participants Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups. 2018.1-2020.12
Primary Family history of allergies of the participants Family history of allergies of the participants were evaluated in the respiratory, dermatological and multisystemic groups. 2018.1-2020.12
Primary total IgE The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed. 2018.1-2020.12
Primary FS-IgE The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated. 2018.1-2020.12
Primary HDM-IgE The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed. 2018.1-2020.12
Primary FS-IgG4 The positive rates of FS-IgG4 in respiratory, cutaneous and multi-system groups were evaluated. 2018.1-2020.12
Primary The difference of total-IgE and FS-IgG4 positive rates among the three groups 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. 2018.1-2020.12
Primary The difference of FS-IgE and FS-IgG4 positive rates among the three groups 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. 2018.1-2020.12
Primary Comparison of FS-IgG4 positive rates among the three groups 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. 2018.1-2020.12
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