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RecruitingNCT06076083Updated Nov 22, 2023

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

An observational study in Ankylosing Spondylitis, sponsored by Tae-Hwan Kim. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Tae-Hwan Kim · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
19 Years to 60 Years
Sex
All
01

Study 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."

Read the 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

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • Microbiome
  • ankylosing spondylitis
  • multi-omics data
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's planned enrollment of 600 is above the median of 202 across 256 observational studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

This is the only study on the registry with Tae-Hwan Kim as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

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."

    Time frame: Visit 1 (0week)

Secondary outcomes

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

    Diversity analysis: Alpha and beta diversity analyses are conducted to determine differences in the composition of gut microbiota between healthy individuals and patients. Important feature selection: Differential abundance analysis (e.g., using methods like LEfSe or ANCOM) or machine learning (e.g., random forest, support vector machine) is employed to identify microbiota. Functional profile prediction: In cases where metagenomic analysis is not feasible, the PICRUSt2 program is utilized to predict and analyze functional profiles based on the phylogeny of the microbiota present in healthy individuals and patients.

    Time frame: Follow up Visit (24week)

07

Study locations

2 of 2 sites recruiting
  • Kyung Hee University Medical Center
    Seoul, Kyungheedae-ro 23 02447, Korea, Republic of
    Recruiting
  • Hanyang University Hospital for Rheumatic Diseases
    Seoul, Wangsimni-ro222-1 04763, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06076083
Lead sponsor
Tae-Hwan Kim
Collaborators
Kyunghee University Medical Center
Responsible party
Tae-Hwan Kim (Professor, Hanyang University Seoul Hospital) — Sponsor-investigator
First posted
Oct 10, 2023
Start date
Oct 6, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 22, 2023

Study contacts

Tae-Hwan Kim, MD,PhD
Contact
thkim@hanyang.ac.kr
82-2-2290-9245
Ji-Hui Shin, MS
Contact
sjihui@hanyang.ac.kr
82-2-2290-9252
Tae-Hwan Kim, MD,PhD
principal investigator · Hanyang University Hospital for Rheumatic Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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