Clinical trial NCT03033290: Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases
Official title: Effect of Traditional Chinese Medicine on Gut Microbiota, Physical Constitution, and Allergic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Qi-tonifying regimen
immune-modulation
gut microbiota
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in allergic rhinitis symptom severity
timeFrame: Assessment of symptom severity on Day 0 and 2 months after completing treatment
Secondary outcomes:
measure: Improvement of fatigue
timeFrame: Assessment of fatigue severity on Day 0 and 2 months after completing treatment
measure: Improvement of life quality
timeFrame: Assessment of life quality on Day 0 and 2 months after completing treatment
measure: Detection of gut microbiota
timeFrame: Assessment of gut microbiota on Day 0 and 2 months after completing treatment
measure: Change in serum total and mite specific IgE
timeFrame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
measure: T Cells measurement
timeFrame: Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment
measure: Measurement of cytokines produced by polymorphonuclear leukocytes
timeFrame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
measure: Measurement of cytokines produced by monocytes and lymphocytes
timeFrame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
measure: Detection of dendritic cell function
timeFrame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital, Taoyuan, Taiwan
name: Sien-hung Yang, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Hwang BF, Jaakkola JJ, Lee YL, Lin YC, Guo YL. Relation between air pollution and allergic rhinitis in Taiwanese schoolchildren. Respir Res. 2006 Feb 9;7(1):23. doi: 10.1186/1465-9921-7-23.
citation: Yang SH, Hong CY, Yu CL. Decreased serum IgE level, decreased IFN-gamma and IL-5 but increased IL-10 production, and suppressed cyclooxygenase 2 mRNA expression in patients with perennial allergic rhinitis after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2001 Jun;1(6):1173-82. doi: 10.1016/s1567-5769(01)00051-0.
citation: Yang SH, Hong CY, Yu CL. The stimulatory effects of nasal discharge from patients with perennial allergic rhinitis on normal human neutrophils are normalized after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2002 Nov;2(12):1627-39. doi: 10.1016/s1567-5769(02)00133-9.
citation: Yang SH, Yu CL, Chen YL, Chiao SL, Chen ML. Traditional Chinese medicine, Xin-yi-san, reduces nasal symptoms of patients with perennial allergic rhinitis by its diverse immunomodulatory effects. Int Immunopharmacol. 2010 Aug;10(8):951-8. doi: 10.1016/j.intimp.2010.05.008. Epub 2010 May 28.
citation: Kuroiwa A, Liou S, Yan H, Eshita A, Naitoh S, Nagayama A. Effect of a traditional Japanese herbal medicine, hochu-ekki-to (Bu-Zhong-Yi-Qi Tang), on immunity in elderly persons. Int Immunopharmacol. 2004 Feb;4(2):317-24. doi: 10.1016/j.intimp.2003.12.004.
citation: Yang SH, Kao TI, Chiang BL, Chen HY, Chen KH, Chen JL. Immune-modulatory effects of bu-zhong-yi-qi-tang in ovalbumin-induced murine model of allergic asthma. PLoS One. 2015 Jun 2;10(6):e0127636. doi: 10.1371/journal.pone.0127636. eCollection 2015.
citation: Xie MQ, Liu J, Long Z, Tian DF, Zhao CQ, Yang PC. Modulation of immune tolerance with a Chinese traditional prescription inhibits allergic rhinitis in mice. N Am J Med Sci. 2011 Nov;3(11):503-7. doi: 10.4297/najms.2011.3503.