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

NCT ID: NCT06063044

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Rhinitis, Allergic Asthma, Allergic Conjunctivitis, Allergic Atopic Dermatitis Chronic Urticaria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Respiratory system group

the patients who diagnosed as rhinitis, asthma and conjunctivitis were assigned to the respiratory system group

No interventions assigned to this group

Skin system group

the patients who diagnosed as urticaria and atopic dermatitis were assigned to the skin system group

No interventions assigned to this group

Multiple systems group

the patients who diagnosed with a combination of symptoms from different systems were assigned to the multiple systems group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

8 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huiying Wang

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

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Second Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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No. 2022-0380

Identifier Type: -

Identifier Source: org_study_id

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