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

NCT04938700 | Unknown Phase 4

• 1 other identifier: 2019-276
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic; Asthma; Dermatitis, Atopic; Urticaria

Keywords

Probiotics; Hypersensitivity; Gastrointestinal Microbiome; immunity

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Probiotics intervention group

EXPERIMENTAL

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; Drug: conventional medical treatment

Contrast group

ACTIVE COMPARATOR

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

Interventions

probiotics DRUG

Probiotics as granules can be used for infants and adolescents

Also known as: conventional medical treatment

Probiotics intervention group

conventional medical treatment DRUG

Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc

Contrast group; Probiotics intervention group

Eligibility Criteria

• Age: Up to 14 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial Hospital of TCM: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Zibo Central Hospital: collaborator
• The First People's Hospital of Huzhou: collaborator

Study Sites (1)

Second Affiliated Hospital，School of Medicine，Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma; Dermatitis, Atopic; Urticaria; Hypersensitivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Wang

CONTACT

+18 0571 87783627; marywang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 24, 2021
• Study Start: March 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 24, 2021

Record last verified: 2021-05

Locations

CN (1)