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

Completed

• Conditions: Asthma, Allergic; Atopic Dermatitis; Conjunctivitis, Allergic; Rhinitis, Allergic; Chronic Urticaria

• Registration Number: NCT06063044
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

· Autoimmune diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FS-IgG4	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	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.
Comparison of FS-IgG4 positive rates among the three groups	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.
HDM-IgE	2018.1-2020.12	The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Age of participants	2018.1-2020.12	Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Family history of allergies of the participants	2018.1-2020.12	Family history of allergies of the participants were evaluated in the respiratory, dermatological and multisystemic groups.
FS-IgE	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	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	2018.1-2020.12	Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.
total IgE	2018.1-2020.12	The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Gender ratio of participants	2018.1-2020.12	Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.

Trial Locations

Locations (1)

Second Affiliated Hospital，School of Medicine，Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China