Clinical trial NCT06063044: Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
Official title: Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Asthma, Allergic
Conjunctivitis, Allergic
Atopic Dermatitis
Chronic Urticaria
Keywords: Immunoglobulin E
Immunoglobulin G
Elimination Diets
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Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 407
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Age of participants
timeFrame: 2018.1-2020.12
measure: Gender ratio of participants
timeFrame: 2018.1-2020.12
measure: birth mode of participants
timeFrame: 2018.1-2020.12
measure: Family history of allergies of the participants
timeFrame: 2018.1-2020.12
measure: total IgE
timeFrame: 2018.1-2020.12
measure: FS-IgE
timeFrame: 2018.1-2020.12
measure: HDM-IgE
timeFrame: 2018.1-2020.12
measure: FS-IgG4
timeFrame: 2018.1-2020.12
measure: The difference of total-IgE and FS-IgG4 positive rates among the three groups
timeFrame: 2018.1-2020.12
measure: The difference of FS-IgE and FS-IgG4 positive rates among the three groups
timeFrame: 2018.1-2020.12
measure: Comparison of FS-IgG4 positive rates among the three groups
timeFrame: 2018.1-2020.12
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital，School of Medicine，Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Huiying Wang
role: STUDY_CHAIR
References: