Rhinitis, AllergicNCT06063044
Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
An observational study of Rhinitis, Allergic and Asthma, Allergic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 8 months to 14 years
- Conditions the study is for
- Rhinitis, Allergic, Asthma, Allergic, Conjunctivitis, Allergic
- How many people
- 407 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital，School of Medicine，Zhejiang University
Hangzhou, Zhejiang
About this study
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.
Read the 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.
- Conditions
- Rhinitis, Allergic, Asthma, Allergic, Conjunctivitis, Allergic, Atopic Dermatitis, Chronic Urticaria
- Keywords
- Immunoglobulin E, Immunoglobulin G, Elimination Diets, chlid
- Medical subject headings
- Rhinitis, Allergic, Asthma, Conjunctivitis, Allergic, Dermatitis, Atopic, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of participants
Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Measured: 2018.1-2020.12
Gender ratio of participants
Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Measured: 2018.1-2020.12
birth mode of participants
Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Measured: 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.
Measured: 2018.1-2020.12
total IgE
The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Measured: 2018.1-2020.12
FS-IgE
The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated.
Measured: 2018.1-2020.12
HDM-IgE
The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.
Measured: 2018.1-2020.12
FS-IgG4
The positive rates of FS-IgG4 in respiratory, cutaneous and multi-system groups were evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2018.1-2020.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiying Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063044
- Sponsor's protocol ID
- No. 2022-0380
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
- ClinicalTrials.gov ID
- NCT06063044
- Acronym / sponsor ID
- No. 2022-0380
- Conditions
- Rhinitis, Allergic, Asthma, Allergic, Conjunctivitis, Allergic, Atopic Dermatitis, Chronic Urticaria
- Keywords
- Immunoglobulin E, Immunoglobulin G, Elimination Diets, chlid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- Clinical diagnosis of allergic rhinitis.
- Clinical diagnosis of asthma.
- Clinical diagnosis of conjunctivitis.
- Clinical diagnosis of urticaria.
- Clinical diagnosis of atopic dermatitis.
Key exclusion criteria (1 listed)
- Autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age of participants
Time frame: 2018.1-2020.12
Age of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Gender ratio of participants
Time frame: 2018.1-2020.12
Gender ratio of participants were evaluated in the respiratory, dermatological and multisystemic groups.
birth mode of participants
Time frame: 2018.1-2020.12
Birth mode of participants were evaluated in the respiratory, dermatological and multisystemic groups.
Family history of allergies of the participants
Time frame: 2018.1-2020.12
Family history of allergies of the participants were evaluated in the respiratory, dermatological and multisystemic groups.
total IgE
Time frame: 2018.1-2020.12
The average level of total IgE in the respiratory, cutaneous, and multi-system groups was assessed.
FS-IgE
Time frame: 2018.1-2020.12
The positive rates of FS-IgE in respiratory, cutaneous and multi-system groups were evaluated.
HDM-IgE
Time frame: 2018.1-2020.12
The average level of HDM-IgE in the respiratory, cutaneous, and multi-system groups was assessed.
FS-IgG4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Rhinitis, Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiying Wang study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Asthma, Allergic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of participants (time frame: 2018.1-2020.12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.