Multi-omics Database for Integrative Microbiome Analysis in a Cohort of Korean Patients With Ankylosing Spondylitis
NCT ID: NCT06076083
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2023-10-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
2. Individuals who have consumed lactic acid bacteria (health functional food) within the last 3 months.
Within a pre-planned period from the date of microbiome collection:
1. Individuals with a history of medication use listed in "drug use".
2. Individuals who have received a vaccine within the last 1 month (4 weeks) from the date of microbiome collection.
3. Individuals who have used topical antibiotics or topical steroids on the face, scalp, neck, arms, forearms, and hands within 24 hours of the date of microbiome collection.
4. Individuals who have used vaginal/vulvar medications, including antifungal drugs, within 24 hours from the date of microbiome collection.
5. Patients with acute illness (e.g., moderate or severe disease with or without fever, but sampling can be postponed until the subject recovers).
6. Patients with chronic and clinically significant medical conditions affecting the liver, digestive system, circulatory system, kidney, nervous system, respiratory system, endocrine system, immune system, blood system, malignant tumors, psychiatric history, or history of substance abuse.
7. Individuals who have made drastic changes to their diet for the purpose of rapid weight gain and loss within 4 weeks from the date of microbiome collection.
8. Individuals with gastrointestinal disorders that may affect microbiome analysis and are currently not medically controlled, or who are being treated for symptoms corresponding to the following diseases: Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), Irritable bowel syndrome (requiring medication), ulcers, acute or chronic pancreatitis, etc.
9. Individuals who need to use diapers for urinary incontinence.
10. Individuals who are suspected, based on medical opinion, to have conditions that may affect the collection of samples at the time of microbiome sample collection.
19 Years
60 Years
ALL
No
Sponsors
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Kyunghee University Medical Center
OTHER
Tae-Hwan Kim
OTHER
Responsible Party
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Tae-Hwan Kim
Professor
Principal Investigators
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Tae-Hwan Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University Hospital for Rheumatic Diseases
Locations
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Kyung Hee University Medical Center
Seoul, Kyungheedae-ro 23, South Korea
Hanyang University Hospital for Rheumatic Diseases
Seoul, Wangsimni-ro222-1, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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HI23C0661-MB-AS
Identifier Type: -
Identifier Source: org_study_id