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

Primary Purpose

Rhinitis, Allergic, Asthma, Dermatitis, Atopic

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
probiotics
conventional medical treatment
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic focused on measuring Probiotics, Hypersensitivity, Gastrointestinal Microbiome, immunity

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital,School of Medicine,Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probiotics intervention group

Contrast group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.
sIgE
The changes of sIgE(IU/ml) before and after the application of probiotics; Difference of sIgE between control group and intervention group
IgG4
The changes of IgG4(U/ml) before and after the application of probiotics; Difference of IgG4 between control group and intervention group

Secondary Outcome Measures

Full Information

First Posted
June 3, 2021
Last Updated
June 16, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial Hospital of TCM, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, Zibo Central Hospital, The First People's Hospital of Huzhou
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1. Study Identification

Unique Protocol Identification Number
NCT04938700
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial Hospital of TCM, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, Zibo Central Hospital, The First People's Hospital of Huzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Fifty children(0-14years)with clear diagnosis of allergic rhinitis, asthma,atopic dermatitis and chronic urticaria were selected. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Asthma, Dermatitis, Atopic, Urticaria
Keywords
Probiotics, Hypersensitivity, Gastrointestinal Microbiome, immunity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Contrast group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
probiotics
Other Intervention Name(s)
conventional medical treatment
Intervention Description
Probiotics as granules can be used for infants and adolescents
Intervention Type
Drug
Intervention Name(s)
conventional medical treatment
Intervention Description
Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc
Primary Outcome Measure Information:
Title
The distribution and quantity of intestinal flora(Determination of fecal microecology by 16S rDNA probe hybridization)
Description
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.
Time Frame
1 year
Title
Clinical symptoms rating scale-Allergic rhinitis symptom rating scale (TNSS+TNNSS)
Description
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
Time Frame
1 year
Title
Clinical symptoms rating scale-Asthma Control Score Scale (ACT)
Description
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
Time Frame
1 year
Title
Clinical symptoms rating scale-Dermatology Quality of Life Indicators Inventory (DLQI)
Description
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.
Time Frame
1year
Title
sIgE
Description
The changes of sIgE(IU/ml) before and after the application of probiotics; Difference of sIgE between control group and intervention group
Time Frame
1 year
Title
IgG4
Description
The changes of IgG4(U/ml) before and after the application of probiotics; Difference of IgG4 between control group and intervention group
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang
Phone
+18 0571 87783627
Email
marywang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital,School of Medicine,Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang
Phone
+18 0571 87783627
Email
marywang@zju.edu.cn

12. IPD Sharing Statement

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

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