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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06063044
• Other study ID #: No. 2022-0380
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital,School of Medicine,Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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