NCT03589183

Brief Summary

Inflammatory bowel disease (IBD) is a chronic inflammatory condition for gastrointestinal tract. There have been numerous studies to reveal dysbiosis of fecal/mucosal microbiome composition in IBD patients but actual trend of dysbiosis is strikingly different among patient's ethnicity. In this background, the investigators have composed a prospective cohort of Korean IBD patients in a large academic referral IBD center. Using an integrated multi-omics bioinformatic analysis, the investigators aim to explore gut microbial signatures along with distinct clinical/genetic features, and their potential interplay in patients with IBD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2018Mar 2028

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

10 years

First QC Date

July 5, 2018

Last Update Submit

March 9, 2023

Conditions

Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease

Keywords

Gut MicrobiomeUlcerative colitisCrohn diseaseMulti-omicsPsychometricsanxietydepression

Outcome Measures

Primary Outcomes (1)

  • Composition and diversity of gut microbiome

    Fecal and/or intestinal mucosal samples are obtained from enrolled subjects for metagenomic sequencing. After extracting fecal or mucosal DNA, microbial composition and diversity are measured from 16sRNA high-throuput sequencing or Shotgun method. Data are compared across different disease phenotypes, such as types of disease (ulcrerative colitis versus Crohn's disease), type of treatment and the presence of psychological disorders (anxiety/depression).

    Up to 10 years

Secondary Outcomes (5)

  • Taxonomic profiling of gut microbiome

    Up to 10 years

  • Finding of single nucleotide polymorphisms (SNPs)

    Up to 10 years

  • Finding of serologic biomarkers

    Up to 10 years

  • Correlation between host genotyping and gut microbiome

    Up to 10 years

  • Liquid biopsy biosignatures assessed by single cell RNA-Seq

    Up to 10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We are planned to study all patients with established diagnosis of IBD (Crohn disease or ulcerative colitis) registered in single tertiary referral IBD center (KyungHee University Medical Center).

You may qualify if:

  • Patients with established diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn disease

You may not qualify if:

  • Person with history of using antibiotics or probiotics within previous 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-702, South Korea

RECRUITING

Related Publications (4)

  • Wellcome Trust Case Control Consortium. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature. 2007 Jun 7;447(7145):661-78. doi: 10.1038/nature05911.

    PMID: 17554300BACKGROUND

  • Thia KT, Loftus EV Jr, Sandborn WJ, Yang SK. An update on the epidemiology of inflammatory bowel disease in Asia. Am J Gastroenterol. 2008 Dec;103(12):3167-82. doi: 10.1111/j.1572-0241.2008.02158.x.

    PMID: 19086963BACKGROUND

  • Nishida A, Inoue R, Inatomi O, Bamba S, Naito Y, Andoh A. Gut microbiota in the pathogenesis of inflammatory bowel disease. Clin J Gastroenterol. 2018 Feb;11(1):1-10. doi: 10.1007/s12328-017-0813-5. Epub 2017 Dec 29.

    PMID: 29285689BACKGROUND

  • Huang H, Vangay P, McKinlay CE, Knights D. Multi-omics analysis of inflammatory bowel disease. Immunol Lett. 2014 Dec;162(2 Pt A):62-8. doi: 10.1016/j.imlet.2014.07.014. Epub 2014 Aug 15.

    PMID: 25131220BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood (whole blood and serum), fecal and mucosal sample from each study subjects

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn DiseaseAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Hyo-Jong Kim, MD PhD

    KyungHee University Hospital

    PRINCIPAL INVESTIGATOR

  • Chang Kyun Lee, MD PhD

    KyungHee University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Kyun Lee, M.D.,Ph.D.

CONTACT

82-2-958-8149changkyun.lee@khu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 17, 2018

Study Start

April 1, 2018

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

KR(1)