DNA Exome Sequencing TCM for Sjögren's Syndrome

• Conditions: Sjögren's Syndrome

• Registration Number: NCT03935373
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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

Detailed 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

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-22
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-02
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06
• Primary Completion: 2019-05-15
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunity-related gene expression	One year	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.
Heart rate variability (HRV)	One year	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.
Immunity-related microbiome expression	One year	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.
TCM tongue diagnosis	One year	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.
Immunity-related proteomics expression	One year	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.
TCM pulse diagnosis	One year	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.
TCM pattern	One year	To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control.; TCM pattern is a tool for detecting the constitution.

Trial Locations

Locations (1)

Ching-Mao Chang; 🇨🇳 Taipei, Taiwan (r.o.c.), Taiwan