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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 407

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital，School of Medicine，Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 407 patients were recruited. Of the all patients,141 were assigned to the respiratory system group, 124 to the skin system group and 142 to the multiple system group. The follow-up interval of patients in both groups before and after treatment was more than 3 months, with the longest follow-up interval being two and a half years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Respiratory system group; the patients who diagnosed as rhinitis, asthma and conjunctivitis were assigned to the respiratory system group
Skin system group; the patients who diagnosed as urticaria and atopic dermatitis were assigned to the skin system group
Multiple systems group; the patients who diagnosed with a combination of symptoms from different systems were assigned to the multiple systems group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total IgE	The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.	2018.1-2020.12
FS-IgE	The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated.	2018.1-2020.12
HDM-IgE	The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.	2018.1-2020.12
FS-IgG4	The positive rates of FS-IgG4 in respiratory, cutaneous and multi-system groups were evaluated.	2018.1-2020.12
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
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
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
Age of participants	Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.	2018.1-2020.12
Gender ratio of participants	Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.	2018.1-2020.12
birth mode of participants	Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.	2018.1-2020.12
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Huiying Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Immunoglobulin G; Immunoglobulin E; Elimination Diets; chlid
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Skin Diseases, Vascular; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Chronic Disease; Dermatitis; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Urticaria; Chronic Urticaria
• Other Study ID Numbers: No. 2022-0380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No