NCT04938700

Study on the Correlation Between Intestinal Microecology and Allergic Diseases in Children

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic
• Asthma
• Dermatitis, Atopic
• Urticaria

Interventions

Type	Name	Description
DRUG	probiotics	Probiotics as granules can be used for infants and adolescents
DRUG	conventional medical treatment	Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-03-01
• Completion: 2023-12-01
• First posted: 2021-06-24
• Last updated: 2021-06-24

Locations

1 site across 1 country: China