Ankylosing Spondylitis
Conditions
Keywords
Microbiome, ankylosing spondylitis, multi-omics data
Brief summary
Multicenter Human Derivatives Prospective Cohort Study: Clinical information will be collected from patients with ankylosing spondylitis and their families who have provided research consent. And clinical samples including blood, saliva, feces, and mucosal biopsy tissue (from patients scheduled for sigmoid colonoscopy or routine colonoscopy examinations) will be collected. Multi-omics data production and laboratory analysis will be conducted using the collected samples, followed by integrated bioinformatic analysis using the produced data.
Detailed description
Enrollment of ankylosing spondylitis patients and family controls who meet the exclusion criteria 2) Collection of standard clinical information items 3) Collect biological samples according to standardized protocols 4) Produce microbiome and multi-omics data from biosamples 5) Conduct clinical research using clinical information items and microbiome and multi-omics data
Interventions
None listed
Sponsors
Kyunghee University Medical Center
Tae-Hwan Kim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Ankylosing spondylitis * Age between 19 and 60 at the time of consent * Diagnosis of ankylosing spondylitis based on the Modified New York criteria and the 2010 diagnosis of spondyloarthritis * Willingness to participate voluntarily after comprehensively understanding the study and agreeing to adhere to the specified precautions Family members of patients with ankylosing spondylitis * Age between 19 and 65 * Must be a primary immediate family member (parent, brother, or sister) of the patient, who is related to the patient and has never been diagnosed with ankylosing spondylitis, and currently resides with the patient * Willingness to participate voluntarily after attentively listening to the study's explanation, fully comprehending its details, and agreeing to adhere to the specified precautions
Exclusion criteria
for Ankylosing Spondylitis Patients: 1. Individuals who have taken antibiotics (oral/injected) within the last 3 months. 2. Individuals who have consumed lactic acid bacteria (health functional food) within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect clinical information data for ankylosing spondylitis patients and their families | Visit 1 (0week) | Clinical information data will be collected from both ankylosing spondylitis patients and their families. Biosamples collected from these individuals will be used to establish a multi-omics analysis platform, including the examination of the intestinal microbiome. With this platform, comparative clinical studies will be conducted to uncover the disease's pathophysiology and identify potential biomarkers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multi-omics data for ankylosing spondylitis patients and their families with consent. | Follow up Visit (24week) | Diversity analysis: Alpha and beta diversity analyses are conducted to determine differences in the composition of gut microbiota between healthy individuals and patients. Important feature selection: Differential abundance analysis (e.g., using methods like LEfSe or ANCOM) or machine learning (e.g., random forest, support vector machine) is employed to identify microbiota. Functional profile prediction: In cases where metagenomic analysis is not feasible, the PICRUSt2 program is utilized to predict and analyze functional profiles based on the phylogeny of the microbiota present in healthy individuals and patients. |
Countries
South Korea
Contacts
Primary ContactTae-Hwan Kim, MD,PhD
Backup ContactJi-Hui Shin, MS
Outcome results
None listed