Clinical trial NCT04938700: Study on the Correlation Between Intestinal Microecology and Allergic Diseases in Children
Official title: Study on the Correlation Between Intestinal Microecology and Allergic Diseases in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rhinitis, Allergic
Asthma
Dermatitis, Atopic
Urticaria
Keywords: Probiotics
Hypersensitivity
Gastrointestinal Microbiome
immunity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Hospital of TCM
name: The Children's Hospital of Zhejiang University School of Medicine
name: The First Affiliated Hospital with Nanjing Medical University
name: Zibo Central Hospital
name: The First People's Hospital of Huzhou
First posted: 2021-06-24
Enrollment: 200
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. Fifty children（0-14years）with clear diagnosis of allergic rhinitis, asthma，atopic dermatitis and chronic urticaria were selected.
2. Feces were collected for analysis of fecal flora by 16S rDNA probe hybridization, and the correlation between the fecal flora and clinical symptom scoring scale, serum sIgE and IgG4 was analyzed.
3. Using probiotics intervention or conventional symptomatic drug intervention, the feces of the children were collected again after 3 months and 6 months for intestinal flora detection, and the correlation with clinical symptoms was observed. Probiotics for granules a blunt and can be used for infants and young children and adolescents, conventional drugs within 2 years old infant antihistamines for children drops, nasal drops and atomization inhalation antiasthmatic, 2-5 years of age can contain montelukast sodium chewing tablets, children over the age of five, including inhaled corticosteroids, oral antihistamines and montelukast sodium chewing tablets and expectorant drugs.
4. Inclusion criteria: patients with allergic rhinitis, asthma, atopic dermatitis or urticaria aged 0-14 years with elevated serum total IgE were clinically diagnosed as allergic patients.
5. Exclusion criteria: patients who withdrew due to treatment intolerance or other reasons during the treatment process.

The study involved children, but the feces were collected and measured in vitro, which was harmless to children.

Eligibility criteria: Inclusion Criteria:

* Elevated serum total IgE in patients with allergic rhinitis, asthma, atopic dermatitis, and chronic urticaria aged 0-14 years

Exclusion Criteria:

* Patients who withdraw during treatment due to treatment intolerance or other reasons

Primary outcomes:
measure: The distribution and quantity of intestinal flora（Determination of fecal microecology by 16S rDNA probe hybridization）
timeFrame: 1 year
measure: Clinical symptoms rating scale-Allergic rhinitis symptom rating scale （TNSS+TNNSS）
timeFrame: 1 year
measure: Clinical symptoms rating scale-Asthma Control Score Scale (ACT)
timeFrame: 1 year
measure: Clinical symptoms rating scale-Dermatology Quality of Life Indicators Inventory (DLQI)
timeFrame: 1year
measure: sIgE
timeFrame: 1 year
measure: IgG4
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital，School of Medicine，Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wang
role: STUDY_CHAIR
References: