Clinical trial NCT06076083: Multi-omics Database for Integrative Microbiome Analysis in a Cohort of Korean Patients With Ankylosing Spondylitis
Official title: Multicentar, Prospective Human Derived Materail Research for Two Group Cohort (Ankylosing Spondylitis Patient and Patient Family)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis
Keywords: Microbiome
ankylosing spondylitis
multi-omics data
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Kyunghee University Medical Center
First posted: 2023-10-10
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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.

Primary outcomes:
measure: Collect clinical information data for ankylosing spondylitis patients and their families
timeFrame: Visit 1 (0week)
Secondary outcomes:
measure: Multi-omics data for ankylosing spondylitis patients and their families with consent.
timeFrame: Follow up Visit (24week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
state: Kyungheedae-ro 23
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital for Rheumatic Diseases
state: Wangsimni-ro222-1
Study officials:
affiliation: Hanyang University Hospital for Rheumatic Diseases
name: Tae-Hwan Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: