DNA Exome Sequencing TCM for Sjögren's Syndrome

Sjögren's Syndrome Clinical Trial

Official title:

Using the DNA Exome Sequencing Tools to Explore the Association Among Gene Sequence, TCM Pattern, TCM Tongue Diagnosis and TCM Pulse Diagnosis for Sjögren's Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03935373
• Other study ID #: 2017-09-006C#3
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Description:

Objective: To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Method:

This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.

Expected Results:

1. To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.

2. To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.

3. To evaluate the proteomics for the Sjögren's syndrome and healthy control.

4. To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.

5. To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.

Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Sjögren's syndrome

Inclusion Criteria:

• (1) primary or secondary SS

• (2) aged between 20 and 75 years

• (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)

• (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations.

Exclusion Criteria:

• (1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition

• (2) pregnancy or breastfeeding

• (3) steroid pulse therapy within three months prior to the commencement of our study.

Health Subjects

Inclusion Criteria:

• (1) aged 20 and 75 years

• (2) had no chronic inflammatory illness.

Exclusion Criteria:

• (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition

• (2) pregnancy or breastfeeding

• (3) abnormal findings of immune, liver, kidney, or blood function evaluations

• (4) total sleeping time insufficiency less than 6 hours before one day of enrollment

• (5) ever took the conventional medicine or hormone within one month

• (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Diagnostic Test:
• DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
• Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
• Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
• RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
• Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
• Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
• Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
• Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
• Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
• Schirmer's test
Sjögren's syndrome patients will take the Schirmer's test.
• Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)

Locations

Country	Name	City	State
Taiwan	Ching-Mao Chang	Taipei	Taiwan (r.o.c.)

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunity-related gene expression	To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.; DNA exome combine the GATK (Genome Analysis Toolkit) is a tool for detecting the ratio of immunity-related gene expression.	One year
Primary	TCM pattern	To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control.; TCM pattern is a tool for detecting the constitution.	One year
Primary	TCM tongue diagnosis	To evaluate the difference of TCM tongue diagnosis between Sjögren's syndrome and healthy control.; TCM tongue diagnosis is a tool for detecting tongue expression.	One year
Primary	TCM pulse diagnosis	To evaluate the difference of TCM pulse diagnosis between Sjögren's syndrome and healthy control.; TCM pulse diagnosis is a tool for detecting pulse of radial artery.	One year
Primary	Heart rate variability (HRV)	To evaluate the difference of Heart rate variability (HRV) between Sjögren's syndrome and healthy control.; HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity.	One year
Primary	Immunity-related proteomics expression	To evaluate the proteomics for the Sjögren's syndrome and healthy control.; Proteomics is a tool for detecting the ratio of immunity-related proteomics expression.	One year
Primary	Immunity-related microbiome expression	To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.; Oral microbiome is a tool for detecting the ratio of immunity-related microbiome expression.	One year