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NCT Number: NCT06076083

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

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."

Recruiting

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyung Hee University Medical Center, Seoul, Kyungheedae-ro 23, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

for Family Members of Ankylosing Spondylitis Patients:

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.

Treatment and study plan

Primary outcomes

  1. Collect clinical information data for ankylosing spondylitis patients and their families

    Time frame: Visit 1 (0week)

    "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."

Secondary outcomes

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

    Time frame: Follow up Visit (24week)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji-Hui Shin, MS

CONTACT

[email protected]

82-2-2290-9252

Tae-Hwan Kim, MD,PhD

CONTACT

[email protected]

82-2-2290-9245

Sponsors and collaborators

Lead sponsor

Tae-Hwan Kim

Other

Collaborators

  • Kyunghee University Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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