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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938700
• Other study ID #: 2019-276
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wang
• Phone: +18 0571 87783627
• Email: marywang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital,School of Medicine,Zhejiang University	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First People's Hospital Affiliated to Huzhou University, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, Zhejiang Provincial Hospital of TCM, Zibo Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	sIgE	The changes of sIgE(IU/ml) before and after the application of probiotics; Difference of sIgE between control group and intervention group	1 year
Primary	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