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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04938700
Enrollment
200
Registered
2021-06-24
Start date
2020-03-01
Completion date
2023-12-01
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Asthma, Dermatitis, Atopic, Urticaria

Keywords

Probiotics, Hypersensitivity, Gastrointestinal Microbiome, immunity

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

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.

Interventions

DRUGprobiotics

Probiotics as granules can be used for infants and adolescents

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The distribution and quantity of intestinal flora(Determination of fecal microecology by 16S rDNA probe hybridization)1 yearThe 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)1 yearThe 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)1 yearThe 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)1yearThe 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.
sIgE1 yearThe changes of sIgE(IU/ml) before and after the application of probiotics; Difference of sIgE between control group and intervention group
IgG41 yearThe changes of IgG4(U/ml) before and after the application of probiotics; Difference of IgG4 between control group and intervention group

Countries

China

Contacts

Primary ContactWang
marywang@zju.edu.cn+18 0571 87783627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026