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Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

Primary Purpose

Allergic Rhinitis

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Bu-Zhong-Yi-Qi-Tang
placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Qi-tonifying regimen, immune-modulation, gut microbiota

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bu-Zhong-Yi-Qi-Tang (BZYQT)

placebo control

Arm Description

capsule of BZYQT, 4gm tid, 12gm a day for 2 months

similar placebo capsule 4gm tid, 12gm a day for 2 months

Outcomes

Primary Outcome Measures

Changes in allergic rhinitis symptom severity
Sino-nasal Outcome Test (SNOT-22)

Secondary Outcome Measures

Improvement of fatigue
Fatigue Severity Scale
Improvement of life quality
SF-36
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
Change in serum total and mite specific IgE
check serum total IgE and mite specific IgE (KIU/l)
T Cells measurement
check CD4 / CD8 by flowcytometry
Measurement of cytokines produced by polymorphonuclear leukocytes
check sICAM-1,IL-8,PGE2, LTC4
Measurement of cytokines produced by monocytes and lymphocytes
IL-4、IL-5、IL-10、IL-13、IFN-γ
Detection of dendritic cell function
check IL-10 and IL-12 level

Full Information

First Posted
May 31, 2016
Last Updated
January 24, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03033290
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Qi-tonifying regimen, immune-modulation, gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bu-Zhong-Yi-Qi-Tang (BZYQT)
Arm Type
Experimental
Arm Description
capsule of BZYQT, 4gm tid, 12gm a day for 2 months
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
similar placebo capsule 4gm tid, 12gm a day for 2 months
Intervention Type
Drug
Intervention Name(s)
Bu-Zhong-Yi-Qi-Tang
Intervention Description
Qi-tonifying regimen of traditional Chinese herbal medicine
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo control
Primary Outcome Measure Information:
Title
Changes in allergic rhinitis symptom severity
Description
Sino-nasal Outcome Test (SNOT-22)
Time Frame
Assessment of symptom severity on Day 0 and 2 months after completing treatment
Secondary Outcome Measure Information:
Title
Improvement of fatigue
Description
Fatigue Severity Scale
Time Frame
Assessment of fatigue severity on Day 0 and 2 months after completing treatment
Title
Improvement of life quality
Description
SF-36
Time Frame
Assessment of life quality on Day 0 and 2 months after completing treatment
Title
Detection of gut microbiota
Description
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
Time Frame
Assessment of gut microbiota on Day 0 and 2 months after completing treatment
Title
Change in serum total and mite specific IgE
Description
check serum total IgE and mite specific IgE (KIU/l)
Time Frame
Assessment of serologic markers on Day 0 and 2 months after completing treatment
Title
T Cells measurement
Description
check CD4 / CD8 by flowcytometry
Time Frame
Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment
Title
Measurement of cytokines produced by polymorphonuclear leukocytes
Description
check sICAM-1,IL-8,PGE2, LTC4
Time Frame
Assessment of serologic markers on Day 0 and 2 months after completing treatment
Title
Measurement of cytokines produced by monocytes and lymphocytes
Description
IL-4、IL-5、IL-10、IL-13、IFN-γ
Time Frame
Assessment of serologic markers on Day 0 and 2 months after completing treatment
Title
Detection of dendritic cell function
Description
check IL-10 and IL-12 level
Time Frame
Assessment of serologic markers on Day 0 and 2 months after completing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sien-hung Yang, Ph.D.
Phone
+886-3-3196200
Ext
2611
Email
dryang@ms1.hinet.net
First Name & Middle Initial & Last Name or Official Title & Degree
YI-Hsuan Lin, M.D.
Phone
+886-3-3196200
Ext
2611
Email
cynthiajobo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sien-hung Yang, Ph.D.
Organizational Affiliation
Chang Gung Memorial Hospital, Taoyuan, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Hsuan Lin, M.D.
Phone
+886-3-3196200
Ext
2611
Email
cynthiajobo@gmail.com
First Name & Middle Initial & Last Name & Degree
Sien-hung Yang, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16469096
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.
Results Reference
background
PubMed Identifier
11407311
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.
Results Reference
background
PubMed Identifier
12469937
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.
Results Reference
background
PubMed Identifier
20546945
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.
Results Reference
background
PubMed Identifier
14996423
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.
Results Reference
background
PubMed Identifier
26035827
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.
Results Reference
background
PubMed Identifier
22361496
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.
Results Reference
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Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

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