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| Name | Class |
|---|---|
| Zhejiang Provincial Hospital of TCM | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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Allergic diseases, including allergic reactions of respiratory tract and skin, are often triggered by mast cell degranulation mediated by allergen-specific IgE and chronic inflammation of target organs, which are involved in a variety of immune cells and inflammatory factors. Recent studies have shown that intestinal immunity is closely related to immune responses to various diseases. Intestinal microecology influences the occurrence and regression of various diseases by regulating the growth, differentiation and maturation of various immune cells. Probiotics are widely used in children with allergies. This study aims to analyze the correlation between the intestinal microecology of children with rhinitis/asthma, eczema and urticaria and the clinical manifestations of the patients. By observing the influence of probiotics intervention on clinical symptoms and changes in intestinal microecology, the influence of intestinal microecology on children's allergic diseases was clarified. Study protocol: 1) children with definitive diagnosis of allergic rhinitis, asthma,atopic dermatitis and chronic urticaria were enrolled, each with 50 cases. 2) collect manure application of 16s rDNA probe hybridization technique to analyze the fecal flora, and compared with clinical symptoms rating scale and serum sIgE, IgG4 correlation analysis (3) application of probiotic intervention or conventional drug intervention, again in 3 months, 6 months after collecting dung is used to detect the intestinal flora in children with its correlation with clinical symptoms change were observed.
The study involved children, but the feces were collected and measured in vitro, which was harmless to children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics intervention group | Experimental | children with definitive diagnosis of allergic rhinitis, asthma,atopic dermatitis and chronic urticaria were enrolled, each with 25 cases. 2) collect manure application of 16s rDNA probe hybridization technique to analyze the fecal flora, and compared with clinical symptoms rating scale and serum sIgE, IgG4 correlation analysis (3) application of probiotic intervention and conventional drugs, again in 3 months, 6 months after collecting dung is used to detect the intestinal flora in children with its correlation with clinical symptoms change were observed. |
|
| Contrast group | Active Comparator | children with definitive diagnosis of allergic rhinitis, asthma,atopic dermatitis and chronic urticaria were enrolled, each with 25 cases. 2) collect manure application of 16s rDNA probe hybridization technique to analyze the fecal flora, and compared with clinical symptoms rating scale and serum sIgE, IgG4 correlation analysis (3) application of conventional drugs, again in 3 months, 6 months after collecting dung is used to detect the intestinal flora in children with its correlation with clinical symptoms change were observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Drug | Probiotics as granules can be used for infants and adolescents |
|
| Measure | Description | Time Frame |
|---|---|---|
| The distribution and quantity of intestinal flora(Determination of fecal microecology by 16S rDNA probe hybridization) | The changes of intestinal flora before and after the application of probiotics;Difference of intestinal flora distribution between control group and intervention group.Determination of fecal microecology by 16S rDNA probe hybridization. It included intestinal flora balance, flora diversity, bacterial strain number and pathogenic bacteria detection. | 1 year |
| Clinical symptoms rating scale-Allergic rhinitis symptom rating scale (TNSS+TNNSS) | The changes of clinical symptoms rating scale before and after the application of probiotics; Difference of clinical symptoms rating scale between control group and intervention group.Allergic rhinitis symptom rating scale TNSS+TNNSS,the minimum value is 1,the maximum value is 4,and higher scores mean a worse outcome | 1 year |
| Clinical symptoms rating scale-Asthma Control Score Scale (ACT) | The changes of clinical symptoms rating scale before and after the application of probiotics; Difference of clinical symptoms rating scale between control group and intervention group.Asthma Control Score Scale (ACT),the minimum value is 1,the maximum value is 5,and higher scores mean a worse outcome | 1 year |
| Clinical symptoms rating scale-Dermatology Quality of Life Indicators Inventory (DLQI) | The changes of clinical symptoms rating scale before and after the application of probiotics; Difference of clinical symptoms rating scale between control group and intervention group.Dermatology Quality of Life Indicators Inventory (DLQI):the minimum value is 0,the maximum value is 3,and higher scores mean a worse outcome. | 1year |
| sIgE | The changes of sIgE(IU/ml) before and after the application of probiotics; Difference of sIgE between control group and intervention group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang | Contact | +18 0571 87783627 | marywang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital,School of Medicine,Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| D003876 | Dermatitis, Atopic |
| D014581 | Urticaria |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Zibo Central Hospital | OTHER_GOV |
| The First People's Hospital of Huzhou | OTHER |
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| conventional medical treatment | Drug | Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc |
|
| 1 year |
| IgG4 | The changes of IgG4(U/ml) before and after the application of probiotics; Difference of IgG4 between control group and intervention group | 1 year |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D017445 | Skin Diseases, Vascular |
| D019602 |
| Food and Beverages |