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

Sponsoren

Hauptsponsor: Taipei Veterans General Hospital, Taiwan

Quelle Taipei Veterans General Hospital, Taiwan
Kurze Zusammenfassung

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

detaillierte Beschreibung

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

Gesamtstatus Active, not recruiting
Anfangsdatum April 1, 2019
Fertigstellungstermin December 31, 2019
Primäres Abschlussdatum May 15, 2019
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
Immunity-related gene expression One year
TCM pattern One year
TCM tongue diagnosis One year
TCM pulse diagnosis One year
Heart rate variability (HRV) One year
Immunity-related proteomics expression One year
Immunity-related microbiome expression One year
Einschreibung 40
Bedingung
Intervention

Interventionsart: Diagnostic Test

Interventionsname: DNA Exome sequencing

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

Interventionsart: Diagnostic Test

Interventionsname: Oral microbiome

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

Interventionsart: Diagnostic Test

Interventionsname: Proteomics

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

Interventionsart: Diagnostic Test

Interventionsname: RNA sequencing

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

Interventionsart: Diagnostic Test

Interventionsname: Cytokine

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

Interventionsart: Diagnostic Test

Interventionsname: Traditional Chinese Medicine pattern

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

Interventionsart: Diagnostic Test

Interventionsname: Traditional Chinese Medicine tongue diagnosis

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

Interventionsart: Diagnostic Test

Interventionsname: Traditional Chinese Medicine pulse diagnosis

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

Interventionsart: Diagnostic Test

Interventionsname: Heart rate variability

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

Interventionsart: Diagnostic Test

Interventionsname: Schirmer's test

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

Armgruppenetikett: Sjögren's syndrome

Interventionsart: Diagnostic Test

Interventionsname: Blood function test, liver function test, kidney function test, and immune function test

Beschreibung: 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)

Teilnahmeberechtigung

Probenahmeverfahren: Probability Sample

Kriterien:

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.

Geschlecht: All

Mindestalter: 20 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Ching-Mao Chang, M.D., Ph.D. Principal Investigator Taipei Veterans General Hospital, Taiwan
Ort
Einrichtung: Ching-Mao Chang
Standort Länder

Taiwan

Überprüfungsdatum

May 2019

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: Sjögren's syndrome

Beschreibung: 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.

Etikette: Health subjects

Beschreibung: 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.

Patientendaten No
Studiendesign Info

Beobachtungsmodell: Case-Control

Zeitperspektive: Cross-Sectional

Quelle: ClinicalTrials.gov