Analyzing the microbiome in Korean patients with ankylosing spondylitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect clinical information and biological samples from patients with ankylosing spondylitis and their immediate family members. The study will gather samples such as blood, saliva, feces, and mucosal biopsies, which will be analyzed to produce microbiome and multi-omics data. The collected data will undergo integrated bioinformatic analysis to explore potential links between the microbiome and ankylosing spondylitis. This approach seeks to enhance understanding of the disease and its underlying mechanisms.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria for Family Members of Ankylosing Spondylitis Patients:

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.

Where it's running

• Kyung Hee University Medical Center
  Seoul, Kyungheedae-ro 23, South Korea Recruiting
• Hanyang University Hospital for Rheumatic Diseases
  Seoul, Wangsimni-ro222-1, South Korea Recruiting

Study contacts

• Principal investigator: Tae-Hwan Kim, MD,PhD — Hanyang University Hospital for Rheumatic Diseases
• Study coordinator: Tae-Hwan Kim, MD,PhD
• Email: thkim@hanyang.ac.kr
• Phone: 82-2-2290-9245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.