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

June 16, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Second Affiliated Hospital，School of Medicine，Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotics intervention group
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.
Drug: probiotics
Probiotics as granules can be used for infants and adolescents
Other Names:
  • conventional medical treatment
Drug: conventional medical treatment
Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc
ACTIVE_COMPARATOR: Contrast group
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.
Drug: conventional medical treatment
Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distribution and quantity of intestinal flora（Determination of fecal microecology by 16S rDNA probe hybridization）
Time Frame: 1 year
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）
Time Frame: 1 year
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)
Time Frame: 1 year
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)
Time Frame: 1year
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
Time Frame: 1 year
The changes of sIgE（IU/ml） before and after the application of probiotics; Difference of sIgE between control group and intervention group
1 year
IgG4
Time Frame: 1 year
The changes of IgG4（U/ml） before and after the application of probiotics; Difference of IgG4 between control group and intervention group
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First People's Hospital of Huzhou
Zibo Central Hospital
The Children's Hospital of Zhejiang University School of Medicine
Zhejiang Provincial Hospital of TCM

Investigators

  • Study Chair: Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (ACTUAL)

June 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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