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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06063044

Enrollment

407

Registered

2023-10-02

Start date

2018-01-01

Completion date

2020-12-31

Last updated

2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Immunoglobulin E, Immunoglobulin G, Elimination Diets, chlid

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Months to 14 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Outcome results