Multi-omics Database for Integrative Microbiome Analysis in a Cohort of Korean Patients With Ankylosing Spondylitis

NCT06076083 | Recruiting DMC

• 1 other identifier: HI23C0661-MB-AS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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."

Conditions

Ankylosing Spondylitis

Keywords

Microbiome; ankylosing spondylitis; multi-omics data

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Multi-omics data for ankylosing spondylitis patients and their families with consent.

  Follow up Visit (24week)

Study Arms (2)

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

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Individuals who have taken antibiotics (oral/injected) within the last 3 months.
• 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:
• Individuals with a history of medication use listed in "drug use".
• Individuals who have received a vaccine within the last 1 month (4 weeks) from the date of microbiome collection.
• 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.
• Individuals who have used vaginal/vulvar medications, including antifungal drugs, within 24 hours from the date of microbiome collection.
• Patients with acute illness (e.g., moderate or severe disease with or without fever, but sampling can be postponed until the subject recovers).
• 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.
• 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.
• 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.
• Individuals who need to use diapers for urinary incontinence.
• 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.

Sponsors & Collaborators

• Tae-Hwan Kim: lead
• Kyunghee University Medical Center: collaborator

Study Sites (2)

Kyung Hee University Medical Center

Seoul, Kyungheedae-ro 23, 02447, South Korea

RECRUITING

Hanyang University Hospital for Rheumatic Diseases

Seoul, Wangsimni-ro222-1, 04763, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 40784769 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, feces, and intestinal mucosal tissue (patients who are scheduled for sigmoid colonoscopy or colonoscopy for routine examination) will be collected.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Tae-Hwan Kim, MD,PhD

  Hanyang University Hospital for Rheumatic Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 10, 2023
• Study Start: October 6, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 22, 2023

Record last verified: 2023-10

Locations

KR (2)