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

Sponsor

Tae-Hwan Kim (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06076083

Collaborator

Kyunghee University Medical Center (Other)

600

Enrollment

Locations

49.5

Anticipated Duration (Months)

300

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

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."

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 14, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Collect clinical information data for ankylosing spondylitis patients and their families [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Medical Center	Seoul	Kyungheedae-ro 23	Korea, Republic of	02447
2	Hanyang University Hospital for Rheumatic Diseases	Seoul	Wangsimni-ro222-1	Korea, Republic of	04763