Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

Study Overview
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Brief Summary
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Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30% and gradually increased annually. However, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. In addition, side effects of western medicine, such as lethargy, mouth dryness were noted. Traditional Chinese medicine, especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by many researchers.This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.

Detailed Description
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Recently studies reported that gut microbiota is related to the human immunity modulation of allergic diseases. Investigators are interested to know weather qi-tonifying herbal medicine is through the changes of gut microbiota to modulate human immunity. In this study, a double-blinded, randomized, placebo control design is applied and total 60 perennial allergic rhinitis patients will be enrolled in our study. All subjects will be divided into Bu-Zhong-Yi-Qi-Tang (BZYQT) and placebo control groups, 40 and 20 subjects each. Subjects of BZYQT group will receive capsule of BZYQT, 4gm tid, 12gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 months treatment course will be done. Gut microbiota will be assayed before and after 2 months treatment. Additionally, various parameters for immunologic response will be checked before and after the treatment, including the total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of cytokine such as IL-10 and IL-12 as well as functional change of dendritic cells and T cells. Results will be analyzed statistically including gender analysis. This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.

Official Title
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Effect of Traditional Chinese Medicine on Gut Microbiota, Physical Constitution, and Allergic Diseases

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Bu-Zhong-Yi-Qi-Tang
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion Diagnosed as intermittent allergic rhinitis (Less than 4 days per week and for less than 4 weeks) CAP panel :allergy to mite Will to complete questionnaires and take medicine as schedule in this study Volunteer for study enrollment and sign inform consent Exclusion Criteria: Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on vasomotor type allergic rhinitis history of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR <60 mL/min/1.73 m2)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bu-Zhong-Yi-Qi-Tang (BZYQT)<br>capsule of BZYQT, 4gm tid, 12gm a day for 2 months | Drug: Bu-Zhong-Yi-Qi-Tang<br>* Qi-tonifying regimen of traditional Chinese herbal medicine<br>|
| Placebo Comparator: placebo control<br>similar placebo capsule 4gm tid, 12gm a day for 2 months | Drug: placebo<br>* placebo control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in allergic rhinitis symptom severity | Sino-nasal Outcome Test (SNOT-22) | Assessment of symptom severity on Day 0 and 2 months after completing treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of fatigue | Fatigue Severity Scale | Assessment of fatigue severity on Day 0 and 2 months after completing treatment | 
| Improvement of life quality | SF-36 | Assessment of life quality on Day 0 and 2 months after completing treatment | 
| Detection of gut microbiota | use cecal stool DNA purification and quantification of cecal microbiota by quantitative PCR (qPCR). Using V3-V5 16S rRNA amplification; Processing of NGS data; Operational Taxonomic Units (OTUs) cluster; Taxonomic profiling | Assessment of gut microbiota on Day 0 and 2 months after completing treatment | 
| Change in serum total and mite specific IgE | check serum total IgE and mite specific IgE (KIU/l) | Assessment of serologic markers on Day 0 and 2 months after completing treatment | 
| T Cells measurement | check CD4 / CD8 by flowcytometry | Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment | 
| Measurement of cytokines produced by polymorphonuclear leukocytes | check sICAM-1,IL-8,PGE2, LTC4 | Assessment of serologic markers on Day 0 and 2 months after completing treatment | 
| Measurement of cytokines produced by monocytes and lymphocytes | IL-4、IL-5、IL-10、IL-13、IFN-γ | Assessment of serologic markers on Day 0 and 2 months after completing treatment | 
| Detection of dendritic cell function | check IL-10 and IL-12 level | Assessment of serologic markers on Day 0 and 2 months after completing treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, Qi-tonifying regimen, immune-modulation