DNA Exome Sequencing TCM for Sjögren's Syndrome

Taipei Veterans General Hospital

Status: Unknown

Conditions: Sjögren's Syndrome

Treatments: Diagnostic Test: RNA sequencing; Diagnostic Test: Oral microbiome; Diagnostic Test: Traditional Chinese Medicine pattern; Diagnostic Test: Blood function test, liver function test, kidney function test, and immune function test; Diagnostic Test: Traditional Chinese Medicine pulse diagnosis; Diagnostic Test: Proteomics; Diagnostic Test: DNA Exome sequencing; Diagnostic Test: Cytokine; Diagnostic Test: Traditional Chinese Medicine tongue diagnosis; Diagnostic Test: Schirmer's test; Diagnostic Test: Heart rate variability

Study type: Observational

Funder types: Other

Identifiers

NCT03935373

2017-09-006C#3

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

40 participants in 2 patient groups

Sjögren's syndrome

Description:

Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the 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. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; or (3) steroid pulse therapy within three months prior to the commencement of our study.

Treatment:

Diagnostic Test: Schirmer's test

Diagnostic Test: Heart rate variability

Diagnostic Test: RNA sequencing

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Cytokine

Diagnostic Test: Proteomics

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Oral microbiome

Diagnostic Test: Blood function test, liver function test, kidney function test, and immune function test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis

Health subjects

Description:

Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 41 and 63 years (which the age could match the SS patients enrolling in the SS-1 trial); (2) had no chronic inflammatory illness. And the exclusion criteria were: (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.

Treatment:

Diagnostic Test: Heart rate variability

Diagnostic Test: RNA sequencing

Diagnostic Test: Traditional Chinese Medicine pattern

Diagnostic Test: Cytokine

Diagnostic Test: Proteomics

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Oral microbiome

Diagnostic Test: Blood function test, liver function test, kidney function test, and immune function test

Diagnostic Test: Traditional Chinese Medicine pulse diagnosis

Diagnostic Test: Traditional Chinese Medicine tongue diagnosis