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Completed

NCT Number: NCT06063044

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.

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Key information

Conditions

Rhinitis, Allergic Asthma Asthma, Allergic Atopic Dermatitis Bronchial Diseases Chronic Disease Chronic Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Dermatitis Dermatitis, Atopic Disease Attributes Eye Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

8 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital，School of Medicine，Zhejiang University

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Age of participants

    Time frame: 2018.1-2020.12

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

  2. Gender ratio of participants

    Time frame: 2018.1-2020.12

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

  3. birth mode of participants

    Time frame: 2018.1-2020.12

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

  4. Family history of allergies of the participants

    Time frame: 2018.1-2020.12

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

  5. total IgE

    Time frame: 2018.1-2020.12

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

  6. FS-IgE

    Time frame: 2018.1-2020.12

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

  7. HDM-IgE

    Time frame: 2018.1-2020.12

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

  8. FS-IgG4

    Time frame: 2018.1-2020.12

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

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

    Time frame: 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.

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

    Time frame: 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.

  11. Comparison of FS-IgG4 positive rates among the three groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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