Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

Phase 3

• Conditions: Allergic Rhinitis
• Interventions: Drug: Bu-Zhong-Yi-Qi-Tang; Drug: placebo

• Registration Number: NCT03033290
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Status Verified: 2018-01
• Study Start: 2018-01-10
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. With at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion
2. Diagnosed as intermittent allergic rhinitis (Less than 4 days per week and for less than 4 weeks)
3. CAP panel :allergy to mite
4. Will to complete questionnaires and take medicine as schedule in this study
5. Volunteer for study enrollment and sign inform consent

Exclusion Criteria

1. Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month
2. Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on
3. vasomotor type allergic rhinitis
4. history of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine
5. severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR <60 mL/min/1.73 m2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bu-Zhong-Yi-Qi-Tang (BZYQT)	Bu-Zhong-Yi-Qi-Tang	capsule of BZYQT, 4gm tid, 12gm a day for 2 months
placebo control	placebo	similar placebo capsule 4gm tid, 12gm a day for 2 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement of life quality	Assessment of life quality on Day 0 and 2 months after completing treatment	SF-36
Improvement of fatigue	Assessment of fatigue severity on Day 0 and 2 months after completing treatment	Fatigue Severity Scale
Detection of gut microbiota	Assessment of gut microbiota on Day 0 and 2 months after completing treatment	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
Change in serum total and mite specific IgE	Assessment of serologic markers on Day 0 and 2 months after completing treatment	check serum total IgE and mite specific IgE (KIU/l)
T Cells measurement	Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment	check CD4 / CD8 by flowcytometry
Measurement of cytokines produced by polymorphonuclear leukocytes	Assessment of serologic markers on Day 0 and 2 months after completing treatment	check sICAM-1,IL-8,PGE2, LTC4
Measurement of cytokines produced by monocytes and lymphocytes	Assessment of serologic markers on Day 0 and 2 months after completing treatment	IL-4、IL-5、IL-10、IL-13、IFN-γ
Detection of dendritic cell function	Assessment of serologic markers on Day 0 and 2 months after completing treatment	check IL-10 and IL-12 level

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan