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| Name | Class |
|---|---|
| Kyunghee University Medical Center | OTHER |
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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."
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ankylosing spondylitis patients | Ankylosing spondylitis Cohort consists of individuals aged 19 to 60 who, at the time of providing consent, have received a diagnosis of ankylosing spondylitis in accordance with the Modified New York criteria and meet the 2010 diagnosis of spondyloarthritis. These individuals have voluntarily chosen to participate in the study, having fully comprehended its details, and have agreed to adhere to the required precautions. | ||
| ankylosing spondylitis patients their families | Those who are between the ages of 19 and 65 A primary immediate family member (parent/brother/sister) who is related to the patient and has never developed ankylosing spondylitis, and who lives with the patient 3) Those who, after listening to the explanation of this study and fully understanding it, voluntarily decided to participate and agreed to comply with the precautions |
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| Measure | Description | Time Frame |
|---|---|---|
| Collect clinical information data for ankylosing spondylitis patients and their families | "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." | Visit 1 (0week) |
| Measure | Description | Time Frame |
|---|---|---|
| Multi-omics data for ankylosing spondylitis patients and their families with consent. | 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. |
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Inclusion Criteria:
Family members of patients with ankylosing spondylitis
Exclusion Criteria for Ankylosing Spondylitis Patients:
Exclusion Criteria for Family Members of Ankylosing Spondylitis Patients:
Within a pre-planned period from the date of microbiome collection:
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Depending on the contents of the Ministry of Health and Welfare's hospital-based human microbiome research and development project, the analysis method may change in the future.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-Hwan Kim, MD,PhD | Contact | 82-2-2290-9245 | thkim@hanyang.ac.kr | |
| Ji-Hui Shin, MS | Contact | 82-2-2290-9252 | sjihui@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Tae-Hwan Kim, MD,PhD | Hanyang University Hospital for Rheumatic Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Medical Center | Recruiting | Seoul | Kyungheedae-ro 23 | 02447 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40784769 | Derived | Kim HS, Kim BH, Nam B, Oh SJ, Park SK, Lee SW, Lee JY, Jo S, Lee YA, Lee JY, Park DI, Kim TH, Lee CK. Oral-gut microbiome axis in a Korean cohort with inflammatory bowel disease and ankylosing spondylitis (INTEGRATE): a prospective and observational study protocol. BMJ Open. 2025 Aug 10;15(8):e092075. doi: 10.1136/bmjopen-2024-092075. |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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blood, saliva, feces, and intestinal mucosal tissue (patients who are scheduled for sigmoid colonoscopy or colonoscopy for routine examination) will be collected.
| Follow up Visit (24week) |
| Hanyang University Hospital for Rheumatic Diseases | Recruiting | Seoul | Wangsimni-ro222-1 | 04763 | South Korea |
|
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |