Analyzing the microbiome in Korean patients with ankylosing spondylitis

Multicentar, Prospective Human Derived Materail Research for Two Group Cohort (Ankylosing Spondylitis Patient and Patient Family)

This study is trying to see how the gut bacteria of Korean patients with ankylosing spondylitis might be connected to their condition by collecting and analyzing samples from them and their families.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 19 Years to 60 Years
• Sex: All
• Sponsor: Hanyang University Seoul Hospital (Academic / other)
• Locations: 2 sites (Seoul, Kyungheedae-ro 23 and 1 other locations)
• Trial ID: NCT06076083 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 19 to 60 diagnosed with ankylosing spondylitis and their immediate family members aged 19 to 65 without the condition.

Not a fit: Patients who have taken antibiotics in the last three months or do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the role of the microbiome in ankylosing spondylitis, potentially leading to new therapeutic strategies.

How similar studies have performed: While the integration of microbiome analysis in rheumatic diseases is a growing field, this specific multi-omics approach in ankylosing spondylitis is relatively novel.

Eligibility criteria

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 this trial is running

Seoul, Kyungheedae-ro 23 and 1 other locations

• 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

Conditions Ankylosing Spondylitis; Microbiome; ankylosing spondylitis; multi-omics data