Clinical trial NCT03935373: DNA Exome Sequencing TCM for Sjögren's Syndrome
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sjögren's syndrome patients and Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.

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

Eligibility 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.

Primary outcomes:
measure: Immunity-related gene expression
timeFrame: One year
measure: TCM pattern
timeFrame: One year
measure: TCM tongue diagnosis
timeFrame: One year
measure: TCM pulse diagnosis
timeFrame: One year
measure: Heart rate variability (HRV)
timeFrame: One year
measure: Immunity-related proteomics expression
timeFrame: One year
measure: Immunity-related microbiome expression
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ching-Mao Chang
state: Taiwan (r.o.c.)
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ching-Mao Chang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: