Building an Integrated Gut Microbiome Data Analysis Platform and Conducting Comparative Clinical Studies in Inflammatory Bowel Disease

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The inflammatory bowel disease (IBD) is a condition that afflects approximately 5 million people worldwide, with 1.4 million in the US and 2.2 million in Europe. By 2030, it is predicted that up to 1% of the entire Western population will have this disease. Notably, IBD encompasses conditions like Crohn's disease (CD) and Ulcerative colitis (UC). The emergence of this disease in non-Western countries is attributed to the rapid urbanization and industrialization which has led to the adoption of Westernized diets, an increase in the use of antibiotics early in life, and air pollution. These factors are suspected to induce changes in the gut microbiome, contributing to the rise of IBD. However, as an immune-mediated chronic intestinal disease, it is a multifactorial condition triggered by genetic mutations, gut microbial features, and environmental factors. Despite numerous studies, the exact causes remain insufficiently understood, emphasizing the importance of research and development to significantly benefit the health of the rapidly increasing patients. The study aims to construct a multi-omics analysis platform, including gut microbiome analysis, using biosamples collected from Korean patients with inflammatory bowel disease (IBD) and their families. Through this platform, comparative clinical research will be conducted to elucidate the pathophysiology of the disease and develop potential biomarkers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 85
Healthy Volunteers: f
View:

• Korean patients with inflammatory bowel disease (including Crohn's disease and ulcerative colitis) aged between 13 and 85 years (at the time of participant consent).

• First-degree blood relatives of the patient, aged between 13 and 85, who have never been diagnosed with IBD and reside with the patient (Family Control Group).

• Participants who have received a detailed explanation about this clinical trial, fully understand it, have voluntarily decided to participate, and have given written consent to comply with the precautions.

Locations
Other Locations
Republic of Korea
Kyunghee University Medical Center
RECRUITING
Seoul
Contact Information
Primary
Chang Kyun Lee, MD, PhD
changkyun.lee@khu.ac.kr
82-2-958-9996
Backup
Shin Ju Oh, MD, PhD
giosj204@gmail.com
82-2-958-9996
Time Frame
Start Date: 2023-10-04
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 900
Treatments
Newly Diagnosed Cohort
Patients who have been diagnosed with inflammatory bowel disease (IBD, including Crohn's disease and ulcerative colitis) for the first time within the last 6 months prior to study enrollment.
Disease Progression Cohort
Patients who were previously diagnosed with IBD and have been followed for over a year to understand disease progression and prognosis.
Drug Cohort
Patients with IBD who, during their tracking observations, begin using biological agents and small molecule drugs for the first time.
Familial IBD cohort
Cases where there are 2 or more diagnosed IBD patients among the patient's first-degree relatives (≥ 2 IBD-affected First Degree Relatives, FDR).
Family Control Group
First-degree blood relatives of the patient who have never been diagnosed with IBD up to the point of study enrollment and who reside with the patient.
Sponsors
Collaborators: Yeungnam University Hospital, Wonkwang University Hospital, Chonnam National University Hospital, Kangbuk Samsung Hospital, Dankook University, Daejeon St. Mary's hospital, Inje University Haeundae Paik Hospital, Soon Chun Hyang University, Keimyung University Dongsan Medical Center, Chung-Ang University Gwangmyeong Hospital, Kyung Hee University Hospital at Gangdong, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Hanyang University, Inje University Ilsan Paik Hospital, Kyungpook National University Hospital
Leads: Chang Kyun Lee

This content was sourced from clinicaltrials.gov