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

NCT06063044 | Completed

• 1 other identifier: No. 2022-0380
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Immunoglobulin E; Immunoglobulin G; Elimination Diets; chlid

Outcome Measures

Primary Outcomes (11)

• 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

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 8 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• · Autoimmune diseases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital，School of Medicine，Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Huiying Wang

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: October 2, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)