An observational study in Rhinitis, Allergic, Asthma, Allergic and Conjunctivitis, Allergic, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 8 Months to 14 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's enrollment of 407 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of allergic rhinitis.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the patients who diagnosed as rhinitis, asthma and conjunctivitis were assigned to the respiratory system group
the patients who diagnosed as urticaria and atopic dermatitis were assigned to the skin system group
the patients who diagnosed with a combination of symptoms from different systems were assigned to the multiple systems group
Age of participants
Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Time frame: 2018.1-2020.12
Gender ratio of participants
Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Time frame: 2018.1-2020.12
birth mode of participants
Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Time frame: 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.
Time frame: 2018.1-2020.12
total IgE
The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Time frame: 2018.1-2020.12
FS-IgE
The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated.
Time frame: 2018.1-2020.12
HDM-IgE
The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Time frame: 2018.1-2020.12
FS-IgG4
The positive rates of FS-IgG4 in respiratory, cutaneous and multi-system groups were evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2018.1-2020.12
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →