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DNA Exome Sequencing TCM for Sjögren's Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03935373
Enrollment
40
Registered
2019-05-02
Start date
2019-04-01
Completion date
2019-12-31
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren's Syndrome

Keywords

Immune regulation, Sjögren's syndrome, Gene modulation, Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis, Traditional Chinese Medicine pulse diagnosis, Proteomics, Oral microbiome

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

Interventions

DIAGNOSTIC_TESTDNA Exome sequencing

The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.

DIAGNOSTIC_TESTOral microbiome

The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.

DIAGNOSTIC_TESTProteomics

The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.

DIAGNOSTIC_TESTRNA sequencing

The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.

DIAGNOSTIC_TESTCytokine

The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.

DIAGNOSTIC_TESTHeart rate variability

Sjögren's syndrome patients and health subjects will take the heart rate variability.

DIAGNOSTIC_TESTSchirmer's test

Sjögren's syndrome patients will take the Schirmer's test.

DIAGNOSTIC_TESTBlood 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)

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Immunity-related microbiome expressionOne yearTo 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.
Immunity-related gene expressionOne yearTo 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.
TCM patternOne yearTo evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control. TCM pattern is a tool for detecting the constitution.
TCM tongue diagnosisOne yearTo evaluate the difference of TCM tongue diagnosis between Sjögren's syndrome and healthy control. TCM tongue diagnosis is a tool for detecting tongue expression.
TCM pulse diagnosisOne yearTo 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.
Heart rate variability (HRV)One yearTo 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 proteomics expressionOne yearTo evaluate the proteomics for the Sjögren's syndrome and healthy control. Proteomics is a tool for detecting the ratio of immunity-related proteomics expression.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026